35

LONG-TERM RESULTS ≥ 5 YEARS AFTER OPEN PYELOPLASTY OR ANTEGRADE ENDOPYELOTOMY FOR URETEROPELVIC JUNCTION OBSTRUCTION

Dobry E., Usai P., Studer U.E., Danuser H.

University Hospital of Bern, Department of Urology, Bern, Switzerland

INTRODUCTION & OBJECTIVES: Little is known about long-term follow-up of corrected UPJ-obstruction. It is also not clear how long and how often patients have to be controlled by regular follow-ups. Therefore, we analysed the rate and time of treatment failures and searched for criteria for how to follow patients.

MATERIAL & METHODS: Ureteropelvic junction obstruction was treated by open pyeloplasty (Anderson-Hynes technique) in 98 cases from 1980-1991 and by antegrade endopyelotomy in 193 cases from 1991-2003. Thirty-nine of 98 patients after open pyeloplasty (median follow-up 139 months (63-251)) and 110 of 193 patients after antegrade endopyelotomy (median follow-up 87 months (60-152)) had a follow-up of more than 5 years. At regular controls 6 and 24 months postoperatively they were assessed clinically, by an excretory urogram (IVU) and/or diuretic renography and clinically and by ultrasound every 2-3 years thereafter.

RESULTS: After open pyeloplasty 2 of the 39 patients with a follow-up of more than five years failed initially but none failed in the long-term follow-up, resulting in a longterm success rate of 95%. After antegrade endopyelotomy 30 of the 110 patients failed. Eighteen of the 30 failures occurred within the first 6 postoperative months, 6/30 failures between 6 and 24 months postoperatively and 6/30 failures more than 2 years postoperatively resulting in a long-term success rate of 73%. None of the late failures had signs of obstruction in the diuretic renal scan or the IVU at the 6 month control.

CONCLUSIONS: Open pyeloplasty is an invasive but very successful procedure with a low failure rate. Long-term success rate of the less invasive antegrade endopyelotomy is 20% less than after open pyeloplasty. Forty percent of the failures occur later than 6 months postoperatively. Therefore regular controls are recommended for at least 5 years.

36

HOW SHOULD WE CORRECT URETEROPELVIC JUNCTION REOBSTRUCTION AFTER FAILED ENDOPYELOTOMY. RESULTS OF SECONDARY PROCEDURES

Danuser H., Dobry E., Burkhard F.C., Hochreiter W., Studer U.E.

University Hospital of Bern, Department of Urology, Bern, Switzerland

INTRODUCTION & OBJECTIVES: Antegrade endopyelotomy has a success rate of 80%, but there are no guidelines for the treatment of failures. Therefore we analyzed the secondary procedures of our endopyelotomy failures.

MATERIAL & METHODS: Forty-two of 195 patients treated with antegrade endopyelotomy for ureteropelvic junction obstruction (UPJO) failed. Except for one patient with an asymptomatic, afunctional kidney, all others (41/42) had further treatment for UPJO: One patient was treated with a permanent double-J-stent. Eighteen patients had minimally invasive retreatment: Laparoscopic nephropexy for a hypermobile kidney (1), retrograde balloon dilatation with additional prolonged stenting (7), retrograde Acucise® endopyelotomy (4), second antegrade endopyelotomy (2) and retrograde laserendopyelotomy (5). Seventeen patients had an open pyeloplasty and 5 had a nephrectomy because of poor kidney function. Therefore 36 of 41 patients had a treatment demanding regular follow-up.

RESULTS: Thirty-one of the 36 patients had a successful secondary procedure and 5 failed a second time. Two of these 5 patients failed after retrograde balloon dilatation and were retreated by open pyeloplasty in one patient and an unsuccessful laser endopyelotomy in another, who later underwent open pyeloplasty. Another 2 of these 5 patients failed again after retrograde laser endopyelotomy. One of them had an open pyeloplasty, the other should have a laparoscopic nephropexy because of a hypermobile kidney. The last of these 5 patients failed after open pyeloplasty and developed a stoneinduced pyonephrosis in a poorly functioning kidney. He had a nephrectomy.

CONCLUSIONS: Open pyeloplasty remains the procedure with the highest success rate (94%) after failed endopyelotomy, and although the most invasive procedure should be recommended first. Minimally invasive procedures such as retrograde balloon dilatation, antegrade endopyelotomies and retrograde Acucise®- or Laser-endopyelotomies have a risk of failure of 22% and does not preclude open pyeloplasty. The hypermobile kidney, a rare disease especially in long, slim ladies, can imitate UPJ-obstruction and should be recognized as an important differential diagnosis.

61

EXPRESSION OF SOME APOPTOSIS-RELATED GENES IN BENIGN PROSTATIC HYPERPLASIA

Bono A.¹, Lama G.², Iacopino F.², Zelano G.³, Sica G.²

¹Ospedale di Circolo e Fondazione Macchi, Department of Urology, Varese, Italy, ²Università Cattolica del Sacro Cuore, Istituto di Istologia ed Embriologia, Rome, Italy, ³Università Cattolica del Sacro Cuore, Istituto di Anatomia, Facoltà ei Medicina & Chirugia, Rome, Italy

INTRODUCTION & OBJECTIVES: Apoptosis plays a fundamental role in regulating the growth and equilibrium of the prostate. Lack of apoptosis regulation is seen as one of the causes of excessive growth in prostate cancer, but the role of apoptosis in benign prostate hyperplasia (BPH) is unclear. Knowledge of the expression of genes involved in apoptosis in benign prostate disease would be of great interest both for a better understanding of the hyper plastic process and for comparing gene expression in benign hyperplasia with that found in cancer. We therefore studied the expression of relevant genes in a series of tissue samples obtained from human benign prostate hyperplasias.

MATERIAL & METHODS: Twenty tissue samples from untreated patients with BPH were studied. The samples were obtained through trans-urethral resection of the hyper plastic gland. Criteria for the selection of patients were: prostate hyperplasia obstructing the bladder outlet and necessitating surgery; absence of clinical history of partial or complete urinary retention; absence of positive urine-culture; plasma PSA and free/total PSA ratio within the normal range; absence of suspicion of prostate cancer on DRE and TRUS; prostate volume not exceeding 50g at ultrasound. Specimens were retrieved in a sterile fashion and immediately frozen in liquid nitrogen. The specimens were then randomly divided and one part was histologically examined to exclude a pre-cancerous lesion or cancer foci and the other was examined using a semi-quantitive Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) technique to study the expression of bcl-2, bax, fas, and c-myc genes. RT-PCR products were electrophoresed on a 1.8% agarose gel, stained with ethidium bromide and then visualised under UV. The intensity of the bands from the gel was quantified by densitometric analysis and normalized to the co-amplified aldolase cDNA fragment.

RESULTS: The average and median rates of gene expression are shown in the table which indicates the ratio between the expression of apoptotic genes and aldolase.

CONCLUSIONS: All four genes investigated were found to be differentially expressed in benign hyper plastic prostatic tissue. Bcl-2 was the least expressed gene whereas cmyc was the most highly expressed. The differences in expression between bcl-2, bax and c-myc were statistically significant. The ratio between bcl-2 and bax was 0.56. In conclusion, our data indicate that the oncogene c-myc is highly expressed, suggesting the presence of a strong proliferative signal within hyper plastic prostate tissue. However, the pro-apoptotic genes are also active in hyperplasia. This could signify that the development of prostate hyperplasia may be due to an imbalance between the activation of the proliferation-associated genes and of pro-apoptosis genes.

141

A COMPARISON OF THE EFFECTS OF REPEATED FILLING ON AMBULATORY AND CONVENTIONAL URODYNAMICS IN MEN WITH LUTS

Kumar V., Shariff U., Chapple C.R., Rosario D.

Royal Hallamshire Hospital, Department of Urology, Sheffield, United Kingdom

INTRODUCTION & OBJECTIVES: The objective of this study was to compare the effects of repeated fill-void cycles in conventional urodynamic study (CUS) with ambulatory urodynamic monitoring (AUM) in men with LUTS suggestive of BOO. We also compared measurement error between AUM and CUS.

MATERIAL & METHODS: CUS was carried out in 45 men in accordance with ICS guidelines at a medium-fill rate of 30 mLmin-1. AUM was performed on a separate cohort of 51 men. All men had LUTS suggestive of a BOO. Each study had 3 fill-void cycles. The outlet condition was defined using Griffiths’ URA and Schäfer’s obstruction coefficient OCO. Detrusor contractility was calculated using Schäfer’s contractility grading and detrusor contractility coefficient DECO. Statistical analysis was carried out using parametric or non-parametric tests as dictated by the distribution of the data.

RESULTS: 43/45 men provided 3 evaluable voids on CUS compared with 47/51 men on AUM. The mean (± 95% CI) voided volume on CUS was 203 ± 18 mL and on AUM was 260 ± 20 mL. On CUS there was statistically significant reduction in pdetQmax with each successive void (p<0.0001 Friedman) but not in Qmax. On AUM there was no significant change in pdetQmax or Qmax. Schäfer obstruction grade was consistent across all 3 voids in 16/43 (37%) men on CUS and 26/47 (55%) men on AUM. Of 10 men in Schäfer II (ICS equivocal obstruction) on the first void during CUS, 6 were unobstructed on subsequent voids. Of 8 men in Schäfer II on first void during AUM, 2 were unobstructed on subsequent voids. During CUS, obstruction grade fell significantly as evidenced by reduction in URA and OCO from void 1 to void 3 (p<0.001, Friedman). There was a trend towards a reduction in contractility grade between voids 1 and 3 (p=0.08, Wilcoxon). During AUM, URA and OCO remained unaltered across all 3 voids. There was a significant rise in contractility between voids 1 and 3 (p=0.02, Wilcoxon) on AUM. The within subjects standard deviations (Sw) for URA, OCO and DECO on CUS and AUM were comparable. (Table).

CONCLUSIONS: Marked differences exist between AUM and CUS in the response of lower urinary tract to repeated filling. In particular, reduction in contractility seen on CUS accompanied by a reduction in the measured obstruction grade could lead to under diagnosis of BOO in men with existing detrusor hypo contractility. AUM gives more consistent results attributable to the more physiological nature of this investigation.

147

RISK FACTORS FOR DISEASE PROGRESSION IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS/BENIGN PROSTATIC HYPERPLASIA; A SYSTEMATIC ANALYSIS OF EXPERT OPINION

Lowe F.¹, Batista J.², Chartier Kastler E.³, Conti G.⁴, Dreikorn K.⁵, O' Leary M.⁶, Stoevelaar H.7

¹St. Luke's Roosevelt Hospital Centre, Urology, New York, United States, ²Fundacion Puivert, Urology, Barcelona, Spain, ³G H Pitié Salpétrière, Urology, Paris, France, ⁴Ospedale S. Anna, Urology, Como, Italy, ⁵Zentralkrankenhaus St. Juergenstrasse, Urology, Bremen, Germany, ⁶Brigham & Women's Hospital, Urology, Boston, United States, ⁷Erasmus University Medical Centre, Institute Medical Technology Assessment, Rotterdam, The Netherlands

INTRODUCTION & OBJECTIVES: Disease progression has become an important issue in the ongoing debate on the appropriate management of LUTS/BPH. Although several risk factors/clinical variables that predict symptom deterioration, serious complications such as acute urinary retention and/or the need for surgical intervention have been identified, no specific patient risk profiles have been established that are useful in the day-to-day management of LUTS/BPH. This study aimed to identify risk factors for progression based on expert opinion.

MATERIAL & METHODS: 12 international urologists assessed the risk of progression for 324 hypothetical patients/cases which were combinations of the values of 6 clinical variables considered as potential risk factors for progression (see table). For all cases, panellists rated the risk of progression on a 3-point scale (1=low, 2=intermediate, 3=high). Logistic regression analysis was used to assess the relative contribution of the 6 risk factors to the risk score.

RESULTS: Fair agreement (>= 8 panellists giving the same score) was seen for 159 cases (49%). Of these cases, 55 (17%) were judged to represent a high risk for progression. Logistic regression showed that the relative contribution of the clinical variables to the panel judgement of high risk was most pronounced for post void residual (PVR) and maximum flow rate (Qmax; see table). The impact of prostate volume, prostate specific antigen (PSA) and symptom severity was modest; age did not show a statistically significant effect. No meaningful interaction effects were found; the impact of the various variables is therefore merely cumulative.

Factors determining the panel judgement of "high risk" of progression (values calculated vs. reference patient with no unfavourable conditions)

CONCLUSIONS: Although not fully supported by the available literature, the panel considered PVR and Qmax as the most important determinants of the risk of disease progression.

148

ARTIFICIAL NEURAL NETWORKS TO PREDICT PROGRESSION IN MEN WITH MILD SYMPTOMS OF BLADDER OUTLET OBSTRUCTION (BOO) UNDER WATCHFUL WAITING FOR 5 YEARS

M. Dobrovits ¹, M. Waldert ¹, B. Djavan ¹, A. Chaudry ², M. Remzi ¹, T. Anagnostou ³, F. Bagheri ², M. Harik ¹, M. Marberger ¹

¹ University of Vienna, Department of Urology, Vienna, Austria, ² University of Pécs, Department of Urology, Pécs, Hungary, ³ University of Athens, Department of Urology, Athens, Greece

INTRODUCTION & OBJECTIVES: Based on our prospective longitudinal multi-centre European study on watchful waiting in men with mild symptoms of BOO (International Prostate Symptom score (IPSS) < 8) and a 5 year follow up, we designed, trained and validated a new Artificial Neural Network based on BPH related clinical and biochemical parameters. The aim of the study was (1) to investigate correlations between clinical, biochemical and urodynamical parameters as well as total and TZ prostate volume, (2) to identify progression parameters in patients presenting with mild symptoms of BOO over a 5 year follow up period and (3) to identify and preselect patients at risk of progression/non-progression.

MATERIAL & METHODS: The artificial neural network (ANN) used in the analysis was an advanced multilayer perceptron selected for accuracy by a genetic algorithm. A tenth-order cross validation methodology was used to ensure proper generalization (non-overfitting). Progression as was included in the analysis, was defined as a change from the mild-IPSS group into the moderate- (IPSS 8-18) or severe IPSS group (IPSS > 18) or an increase in the IPSS score > 3 points-. The occurrence of urinary retention or the need for surgery (TURP) was also qualified as disease progression. Quality of life scores were also recorded separately and cross-analysed. Improvement was defined, based on the same criteria, in the reverse sense.

A total of 1208 patients who presented to 5 European University clinics for LUTS due to BOO were included in this prospective longitudinal study. Patients with an IPSS < 8 were identified and watchful waiting initiated. All were followed for up to 5 years at 3 mo intervals. Measured parameters included age, PSA, IPSS, the total obstructive symptom score (OSS), the irritative symptom score (IRR), the quality of life score (QOL) and the maximal and mean flow rate, total (TPV) and transition zone (TZV) volume were recorded by TRUS for each patient.

RESULTS: 446 of 1208 men evaluated had mild symptoms of BOO (IPSS < 8) and 397 were available for follow up at 5 years. Cumulative progression rate was 12%, 15%, 28%, 31% and 39% at 12 mo, 24 mo, 36 mo, 48 mo and 60 mo, respectively. 60%, 65%, 73%, 71% and 77% deteriorated without shifting to the next higher IPSS category. In contrast, improvement in symptoms was observed in 20%, 17%, 8%, 3% and 2%, respectively at 1, 2, 3, 4 and 5 years, whereas 8%, 10%, 4%, 3% and 2% had stable disease. The overall accuracy of the ANN in predicting disease progression and the need for surgery was 76% and 80%, respectively. The variables of importance for disease progression in the ANN analysis were in order of significance: PSA cut off of 2.0 ng/mL, OSS, age and TZ volume. The combination of a PSA > 2ng/mL and OSS offered an 86% accuracy. The variables IPSS, ISS, QoL, Qmax and mean flow rate as well PVR were not found to add significant predictive value. Overall accuracy was best in patients with PSA greater than 1.5 ng/ml.

CONCLUSIONS: ANNs offer not only reliable tools in patients with prostate cancer they also improve patient selection in men with BPH. In men with mild symptoms of BOO (IPSS<8) under watchful waiting, progression rates to higher IPSS categories (8-18 and 19-35) increase from 12% at 1years to 39% at 5 years. In those not shifting to a higher IPSS category, overall 70% will progress by at least 1point. Improvement is observed in 20% at 1year and decreases to 2% at 5 years. The ANN identified a PSA cut off of 2 ng/mL, OSS and age as best predictors of disease progression, overall symptomatic progression, rate of urinary retention and need for surgery, respectively. The ANN was able to preselect patients at risk for disease progression with an overall accuracy of 86%.

153

EJACULATORY FUNCTION AND SEXUAL SATISFACTION IN AGEING MALES: THE ROLE OF LUTS SEVERITY

R. Rosen ¹

¹ UMDNJ - Robert Wood Johnson Medical School, Department of Psychiatry, Piscataway, United States

INTRODUCTION & OBJECTIVES: To examine the relationships between LUTS severity, ejaculatory function, and sexual satisfaction using a new sexual function scale, the Male Sexual Health Questionnaire (MSHQ).

MATERIAL & METHODS: A 25-item questionnaire has been developed and validated in men with BPH/LUTS and symptoms of sexual dysfunction. Included were 19 items on erection and ejaculation from an earlier study, and 6 additional items assessing sexual satisfaction. Following initial scale validation, 112 participants were stratified according to level of BPH symptom severity and sexual dysfunction (moderate-severe BPH with sexual problems, and mild or no BPH with normal sexual function). The association between sexual satisfaction and scores for BPH/LUTS, erection, and ejaculation were examined, as were the inter-correlations among erection, ejaculation, and sexual satisfaction.

RESULTS: Male participants (n = 112) were primarily > 60 years of age (60%), aucasian (79%), and married (71%). At screening, sexual dysfunction and/or moderate to severe symptoms of BPH/LUTS (IPSS >8) were self-reported by 58 participants. The majority of men in the BPH/LUTS group reported significant ejaculation dysfunction. Results also showed that BPH/LUTS was associated with decreased sexual desire (r= -0.27, P <0.01) and satisfaction (r= -0.26, p <0.01). Analysis of domain inter-correlations showed sexual satisfaction had a stronger relationship to ejaculation function (r= -0.40, P <0.001) than to erectile function (r = -0.22, p < 0.05). Decreased satisfaction with ejaculatory dysfunction is supported by qualitative data showing a reduction in pleasure and sensation among the participants with sexual dysfunction.

CONCLUSIONS: Presence and severity of BPH/LUTS was strongly associated with ejaculation and erectile dysfunction and low levels of sexual satisfaction. Ejaculatory dysfunction was a stronger predictor of low sexual satisfaction than was erectile dysfunction.

185

EFFICACY OF EXTRACORPOREAL MAGNETIC INNERVATION THERAPY (EXMI) IN COMPARISON TO STANDARD THERAPY FOR STRESS, URGE AND MIXED INCONTINENCE: A RANDOMISED PROSPECTIVE TRIAL

H. Madersbacher ¹, S. Pilloni ¹

¹ University Hospital Innsbruck, Neuro-Urology Unit, Innsbruck, Austria

INTRODUCTION & OBJECTIVES: This is a randomised prospective trial, in which the efficacy of ExMI and conservative standard therapy are compared.

MATERIAL & METHODS: 25 females and 1 male, mean age 57 a (27 - 79 a) were treated with ExMI or standard therapy according to randomization (even- and odd-numbered years); 12 suffered from stress-, 5 from overactive bladder (OAB)- and 9 from mixed incontinence. For the ExMI treatment a magnetic chair (NeoControl®) designed by Yamanashi et al., 2000 2) was used. The number of treatment sessions was 20 carried out 3 – 4 times / week for 15 min. over a period of 6 weeks, with 25 - 30 Hz in stress- and 5 - 10 Hz in overactive bl. incontinence. Standard therapy for stress incontinence comprised an intensive individual pelvic floor re-education programme 3 times / week over 6 weeks, the therapy of OAB incontinence comprised non-invasive electrical neuromodulation once daily for 20 min. over 6 weeks - mean period of observation was 95 days with ExMI and 80 days with standard therapy. Primary outcome measures were bother (Visual Analogue Scale), number of pads, max. urethral closure pressure, secondary outcome measures the one-hour pad test and the max. power in perineometry.

RESULTS: Of standard therapy and of ExMI for all patients are presented in table 1 and 2 (Mann-Whitney Test with a significance of p < 0.05), an outcome comparison between standard therapy and ExMI in table 3.

CONCLUSIONS: There was no statistical significance in the primary and secondary outcome measures - the results were virtually identical. ExMI treatment is an alternative and is particularly suitable for elderly pats., which are unable to perform sophisticated re-education programmes.

187

MULTICENTER RANDOMIZED CONTROLLED STUDY TO EVALUATE URYX® URETHRAL BULKING AGENT IN TREATING FEMALE STRESS URINARY INCONTINENCE

J. Corcos ¹, R. Dmoschowski ², S. Herschorn ³, Y. Berger ⁴, A. Bent ⁵, J. Foote ⁶, P. Pommerville ⁷, S. Radomski ⁸, J. Cornella ⁹, K. Jacoby ¹⁰, M. Kennelly ¹¹, V. Lucente ¹², A. Stone ¹³, T. Harris ¹⁴, R. Appell ¹⁵

¹ Jewish General Hospital, McGill University, Department of Urology, Montreal, Quebec, Canada, ² Vanderbilt University Medical Centre, Department of Urologic Surgery, Nashville, Tn, United States, ³ Sunnybrook Health Science Centre, Department of Surgery/Urology, Toronto, On, Canada, ⁴ Associates in Urology, Department of Urology, West Orange, Nj, United States, ⁵ Greater Baltimore Medical Centre, Department of Uro-Gynaecology, Baltimore, Md, United States, ⁶ Shepherd Centre, Department of Urology, Atlanta, Ga, United States, ⁷ Can-med Clinical Research, Department of Urology, Victoria, Bc, Canada, ⁸ Toronto Hospital, Western Division, Department of Urology, Toronto, On, Canada, ⁹ Mayo Clinic, Department of Uro-Gynaecology, Scottsdale, Az, United States, ¹⁰ Northwest Outpatient Medical Centre, Department of Urology, Seattle, Wa, United States, ¹¹ McKay Urology, Department of Urology, Charlotte, Nc, United States, ¹² Institute for Female Pelvic Medicine, Department of Urology, Allentown, Pa, United States, ¹³ UC Davis School of Medicine, Department of Urology, Sacramento, Ca, United States, ¹⁴ The Incontinence and Pelvic Support Institute, Department of Uro-Gynaecology, Mission Viejo, Ca, United States, ¹⁵ Baylor College of Medicine, Department of Urology, Houston, Tx, United States

INTRODUCTION & OBJECTIVES: Periurethral injection of bulking agents is a recognized treatment of stress urinary incontinence (SUI). URYX is an injectable solution of ethylene vinyl alcohol (EVOH) dissolved in dimethyl sulfoxide (DMSO) carrier. Upon contact with an aqueous environment the DMSO dissipates and the EVOH solidifies as a soft spongy mass, creating a bulking effect. The final volume is equivalent to the injected solution, and does not change over time. This study evaluated URYX in treatment of female urinary incontinence.

MATERIAL & METHODS: Two hundred thirty seven (237) females with genuine SUI were randomized and prospectively treated with either URYX or Contigen®, then followed for one year. A maximum of three treatments was allowed in the first 90 days. URYX was easily injected through a 25g needle while Contigen requested a 22g needle. Mean age was 61 years. All patients had failed previous urinary incontinence treatment, with 46% failing at least one surgery. Efficacy was assessed at 12 months following the last treatment using pad weight test, Stamey grade and the Incontinence-Quality of Life (I-QOL) questionnaire. Safety analysis was comprehensive.

RESULTS: Mean total volume injected per patient was 4.7ml of URYX and 7.2ml of Contigen. At 12 months, by pad weight tests, 64% of URYX patients and 42% of Contigen patients were cured (defined as dry pad tests [no leakage]). Another 9% of URYX patients and 16% of Contigen patients were improved (defined as ³50% reduction in pad test weight from baseline). The percentage of patients achieving improvement in Stamey grade of incontinence was the same for both the URYX and Contigen groups (61%). Also, the percentage of patients achieving improvement in I-QOL scores (defined as ³50% increase from baseline score) was the same with both groups (33%). The three most prevalent complications in both treatment arms were delayed voiding, dysuria and UTI. No unanticipated adverse events have been reported in either treatment group.

CONCLUSIONS: URYX is a new promising, non-immunoreactive injectable. We have demonstrated a significantly better cure rate with URYX than with Contigen while injecting less mean volume. There were no significant clinical or safety issues with either product. Study follow-up is near completion and updated results will be provided in the presentation.

188

INJECTABLE MICROBALLOONS FOR STRESS URINARY INCONTINENCE - 5 YEAR RESULTS

P. Quek ¹, H. Teh ¹, P. Lim ¹

¹ Changi General Hospital, Department of Urology, Singapore, Singapore

INTRODUCTION & OBJECTIVES: Long term efficacy of periurethral injectables have been hampered by problems of particle migration and absorption, resulting in volume loss. Long term complications of fibrosis and granuloma formation have also been reported. Silicon elastomer balloons inserted periurethrally and filled with a bio-inert hydrogel were designed to address these issues. As part of a multicentre trial, we treated 18 women with stress urinary incontinence (SUI) with these balloons. Preliminary results at a mean of 17.4 months follow up showed that 38.8% (7/18) were completely dry and 55% (10/18) vastly improved. We now report the 5 year results of this cohort. MRI studies were also performed in 6 women who consented, in whom we looked at balloon position and volume loss 5 years after implantation

MATERIAL & METHODS: Between March 1997 and July 1998, 18 women with urodynamically proven stress incontinence underwent periurethral injection of microballoons. Pre operative and post operative continence was determined by a voiding diary, pad test, video urodynamics (UDS) and King's Health Questionnaire.

RESULTS: The mean age was 47 years, mean parity of 2.6 and mean follow up 60 months (46 to 66 months). 5 patients had had previous anti incontinence surgery. 3 patients were lost to follow up. Of the 15 left, 6/15 were completely dry on UDS, pad test and 2 week voiding diary. 6/15 had more than 75% improvement in leaks per week and pad test and reported overall satisfaction with no desire for further treatment. Mean postoperative leak episodes per week was 0.9 cf 30 pre op and mean post op pad test was 1.14g cf 22g pre op in the improved group.

3 failed treatment and underwent Burch colposuspensions and a TVT respectively. Post op de novo overactive symptoms occurred in 13.6%, no patients went into urinary retention. 4 of the 6 patients with MRI studies showed at least 2 balloons in good position at the bladder neck and this correlated with post operative continence. 9 of the 16 balloons visualised on MRI showed a volume loss of more than 50%.

CONCLUSIONS: Our results show that implantable microballoons come closest to the physical ideals of a bulking agent and have overall 80% patient satisfaction at 5 years. Volume loss seen may be a result of slow seepage or due to technical errors in calculation. The former may be addressed by the new anticontinence therapy (ACT) device that allows further topping up.

226

BOTHER AND IPSS WORSENING UNDER TREATMENT AND HISTORY OF AUR, ARE THE MOST IMPORTANT RISK FACTORS FOR AUR/BPH SURGERY

M. Emberton ¹, G. Vallancien ², A. Alcaraz ³, N. Harving ⁴, J. Van Moorselaar ⁵, H. Matzkin ⁶, R. Hartung ⁷, M. Elhilali ⁸

¹ The Middlesex Hospital, Department of Urology, London, United Kingdom, ² Institut Mutualiste de Montsouris, Department of Urology, Paris, France, ³ Fundacio Puigvert, Department of Urology, Barcelona, Spain, ⁴ Aalborg Sygehus Afsnit Nord, Department of Urology, Aalborg, Denmark, ⁵ University Medical Centre Utrecht, Department of Urology, Utrecht, The Netherlands, ⁶ Tel-Aviv Sourasky Medical Centre, Department of Urology, Tel-Aviv, Israel, ⁷ Urologischen Klinik und Poliklinik Rechts der Isar, Department of Urology, Munich, Germany, ⁸ Royal Victoria Hospital, Department of Urology, Montréal, Canada

INTRODUCTION & OBJECTIVES: To analyse risk factors of disease progression in patients with lower urinary tract symptoms (LUTS) treated with Alfuzosin 10mg OD in real life practice.

MATERIAL & METHODS: By July 11th 2003, 4787 men (mean age 65.3 years, IPSS 17.0, bother score 3.7) were treated with Alfuzosin 10mg OD for 6 months in Europe, Middle-East, Latin America, Asia, Canada. The influence of baseline and outcome clinical characteristics on the risk of disease progression, defined by the occurrence of acute urinary retention (AUR) and/or BPH-related surgery, was tested. Subgroups were compared using cox-proportional hazards analyses.

RESULTS: In this severe population (171/4787 men with history of AUR), the incidence of AUR and/or BPH surgery under Alfuzosin 10mg OD treatment was low (n=95, 2%). The most important risk factors of AUR and/or BPH-related surgery were patients with a bother score>3 and with a rise in IPSS >4 points under treatment. Men who experienced a first AUR before inclusion were about thrice as likely to have BPH progression compared with those without history of AUR. Other variables (age, PSA, baseline IPSS and bother) had much less predictive value.

*last available assessment before AUR/BPH-related surgery event °IPSS 8th question: mostly dissatisfied [4], unhappy [5] or terrible [6] CI: confidence interval

CONCLUSIONS: This 6-month analysis of a real life practice study assessing the long-term efficacy of Alfuzosin 10 mg OD suggests that the most important risk factors of AUR and/or BPH-related surgery are bother and symptom worsening (rise in IPSS of at least 4 points) under treatment, and history of AUR.

233

INTEGRATING RISK PROFILES IN THE TREATMENT CHOICE FOR PATIENTS WITH LOWER URINARY TRACT SYMPTOMS/BENIGN PROSTATIC HYPERPLASIA. A SYSTEMATIC ANALYSIS OF EXPERT OPINIONZ

Speakman M.¹, Berges R.², Desgrandchamps F.¹, Narayan P.⁴, Perez M.⁵, Trachtenberg J.⁶, Tubaro A.⁷, Meesen B.⁸

¹Taunton and Somerset Hospital, Department of Urology, Taunton, United Kingdom, ²Pan Klinik am Neumarkt, Department of Urology, Cologne, Germany, ³CHU Saint Louis, Department of Urology, Paris, France, ⁴Private Practice, Department of Urology, Gainesville, United States, ⁵Medical Sciences University of the Sao Paulo Santa Casa Hospital, Department of Urology, Sao Paulo, Brazil, ⁶University of Toronto & Princess Margaret Hospital, Department of Urology, Toronto, Canada, ⁷Sant' Andrea Hospital, Department of Urology, Rome, Italy, ⁹Ismar Healthcare, Department of Research, Lier, Belgium

INTRODUCTION & OBJECTIVES: To explore the potential role of risk factors for disease progression in the treatment choice for patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

MATERIAL & METHODS: We used a modified Delphi method to investigate the opinion of 12 international experts on the appropriateness of various treatments for different risk profiles. These risk profiles were unique combinations of clinical variables that predict the risk for disease progression (symptom deterioration, complications, need for invasive treatment). These included age, symptom severity (total I-PSS), prostate volume, prostate specific antigen (PSA), maximum flow rate (Qmax) and post-void residual (PVR). For 324 risk profiles/cases, panellists individually rated the appropriateness of 7 treatments (see table) against a reference therapy (a1-adrenoceptor antagonist continuously: α₁-ARc), using a 9-point scale (9=reference treatment is appropriate, 1=alternative treatment is appropriate, 5=equivocal or uncertain). Based on the median score and the extent of agreement, for each of the profiles a panel statement regarding the appropriateness of these treatments was calculated. The relationship between risk factors and panel statements was examined using logistic regression analysis.

RESULTS: Overall, α₁-ARc was considered appropriate in 51% of the cases versus 7% for the alternative treatments. For 42% of the cases, the panel ratings were uncertain. For the majority of cases, treatment with α₁-ARc was considered far more appropriate than watchful waiting (WW), plants and α₁-AR short-term therapy (defined as "until symptoms resolve"). For the appropriateness of α₁-ARc vs. other treatments, the ratings were largely uncertain. Logistic regression analysis showed that a large prostate volume and considerable PVR were the dominant factors in favour of combination therapy and surgery. Panel judgements (%) on appropriateness of 7 treatments (left column) vs. α₁-ARc (right column)

Sum of row totals: 100%; * α₁-ARc + 5α-reductase inhibitor

CONCLUSIONS: Although many ratings were uncertain, α₁-AR continuously was considered far more appropriate for treating LUTS/BPH than watchful waiting, plant extracts, and short-term α₁-AR therapy. The choice for combination therapy or surgery over α₁-AR continuously was mainly determined by a large prostate volume and a considerable PVR.

307

TRANS-OBTURATOR TAPE (TOT) FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE

Droupy S.¹, De Tayrac R.², Delmas V.³, Delorme E.⁴

¹CHU de Bicêtre, Urology, Le Kremlin Bicêtre, France, ²Antoine Béclère, Gynecology, Clamart, France, ³Bichat, Urology, Paris, France, ⁴Clinic, Urology, Chalon sur Saone, France

INTRODUCTION & OBJECTIVES: We report the feasibility and results of a new minimally invasive surgical technique using a tape inserted via a trans-obturator percutaneous route to recreate a mid-urethral backboard for the treatment of stress urinary incontinence.

MATERIAL & METHODS: From May 2000 to December 2002, 90 patients with stress urinary incontinence associated with urethral hypermobility and without genital prolapse were operated by 3 surgeons. Mean age was 59 years (29-87). All patients had pre-operative urodynamic testing. Five patients had intrinsic sphincter deficiency (max. closure urethral pressure less than 20 cm H2O). Sixteen patients had recurrent stress incontinence after open or percutaneous previous procedures. Urgencies were associated in 53/90 patients (58.8%), 13/53 had an overactive bladder on urodynamics. A non elastic, polypropylene tape (Porgès-Mentor) was placed under the mid-urethra. Surgical placement technique used a trans-obturator percutaneous route. No cystoscopy was required for the procedure. All patients were evaluated for follow-up by: questionnaire, clinical examination, cough stress test, uroflometry and residual volume assessment. The following objective and subjective criteria of voiding dysfunction were analysed: Qmax<15ml/s, residual volume >20%, clinical dysuria, de novo urgencies or recurrent urinary infections.

RESULTS: Mean operative time was about 15 minutes. Mean follow-up was 16±4 months. No preoperative complications occurred. 76 patients (84.5%) were completely cured and 10 (11%) patients were significantly improved. Three patients had spontaneously regressive post-operative urinary retention. No urethral erosion. Two vaginal erosions were treated by removal of the silicone part of the tape. 15/90 patients (16.7 %) presented objective and/or subjective criteria of voiding dysfunction. Sexual discomfort was reported by 2 patients during the first two months and spontaneously disappeared.

CONCLUSIONS: This procedure is an effective promising new technique for the surgical treatment of female stress urinary incontinence. Cure rates are similar to other minimally invasive and open sling procedures. The transobturator approach is safe, avoiding bladder, intestinal or vascular injuries and reduces the risk of urinary retention. Further follow-up is needed.

308

EARLY EXPERIENCE WITH 120 PATIENTS AND TRANSOBTURATOR SUBFASCIAL HAMMOCK FOR FEMALE STRESS URINARY INCONTINENCE (SUI)

Jacquetin B.¹, Debodinance P.², Fischer A.³, Marques-Queimadelos A.⁴, Cervigni M.⁵, Rassler J.⁶, Herschorn S.⁷, Urwin G.⁸, Goetze W.⁹, Courtieu C.¹⁰, Schrader M.¹¹, De Ridder D.¹², Mellier G.¹³, Rane A.¹⁴, Ouellet S.¹⁵

¹Maternite Hotel Dieu, Department of Obstetrics/Gynaecology, Clermont Ferrand, France, ²Maternite les Bazennes, Department of Obstetrics/Gynaecology, St. Pol sur Mer, France, ³Krankenhaus Sankt Josef, Department of Gynaecology, Ruedesheim am Rhein, Germany, ⁴Hospital Clinico Universitario, Department of Urology, Santiago de Compostela, Spain, ⁵Universita delgi Studi di Perugia, Department of Uro-Gynaecology, Roma, Italy, ⁶St. Elisabeth-Krankenhaus Leipzig, Department of Urology, Leipzig, Germany, ⁷Sunnybrook Hospital, Department of Urology, Toronto, Canada, ⁸York District Hospital, Department of Urology, York, United Kingdom, ⁹Krankenhaus Strausberg, Department of Gynaecology, Strausberg, Germany, ¹⁰Clinique Beau Soleil, Department of Gynaecology, Montpellier, France, ¹¹Freie Universität Berlin, Department of Urology, Berlin, Germany, ¹²University Hospital KU Leuven, Department of Urology, Leuven, Belgium, ¹³Hopital Edouard Herriot, Department of Gynaecology, Lyon, France, ¹⁴Townsville Hospital, Department of Gynaecology, Townsville, Australia, ¹⁵Les Gynecologues Associes, Department of Gynaecology, Montreal, Canada

INTRODUCTION & OBJECTIVES: Mid-urethral slings using a suprapubic or transvaginal approach have become effective treatments for female SUI due to urethral hypermobility and Intrinsic Sphincter Deficiency (ISD). However, these procedures occasionally cause bladder and/or urethral perforations and more rarely, vascular or bowel injuries. A new transobturator approach avoids the retropubic space, resulting in decreased complications and patient morbidity and is as effective as alternative selffixating slings.

MATERIAL & METHODS: Between Jan. and Sept. 2003, 120 patients were implanted with the Monarctm Subfascial Hammock in a prospective, multicentre study at 15 sites in Europe, Canada, and Australia. Intra and post-op complications were monitored to evaluate safety. Effectiveness was evaluated objectively by physical examination, cough stress test, one-hour pad weight test and subjectively by two patient-completed QoL Questionnaires: Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire Short Form (IIQ-7). Patients will be followed for 24 months.

RESULTS: Mean operative time was 20 minutes; actual sling placement took a mean of 9 minutes. Two of 120 (1.7%) minor intra-operative complications occurred, both temporary urinary retention. All patients went home without a catheter. Patients used an average of 3.5 pads per day preoperatively. Pad use decreased to 0.6 pads/day at 4-6 weeks and 0.3 pads/day at 3 months. 102 of 113 had positive pre-operative cough stress tests. At 4-6 weeks, 7/98 had positive tests and at 3 months, 4/35 had positive cough stress tests. One Hour Pad Weight tests pre-operatively showed a mean pad weight of 71.7 g. Pad weight decreased to 12.8 g at 4-6 weeks and 9.7 g at 3 months. UDI-6/ IIQ-7 Global Scores based on 0-100 Scale (0=highest QoL, 100=lowest)

12 of 120 (10%) patients experienced complications. Urinary tract infections occurred in 5 patients (4.2% of total patients), urge symptoms occurred in 4 patients (3.3%), recurrent incontinence occurred in 2 patients (1.8%), and urge incontinence occurred in 1 patient (0.8%). 4 of 120 patients (3.3%) had surgical revisions to release sling tension or remove slings.

CONCLUSIONS: Objectively, patients enrolled in this study showed a significant decrease in number of pads used per day as well as significant decreases in the pad weights collected during the one-hour pad-weight test. Follow-up visits also showed significant improvements in patient QoL questionnaire responses for both UDI-6 and IIQ-7. In addition, complications seem comparable to other minimally invasive treatments for incontinence. This new transobturator approach for a mid-urethral, selffixating sling shows promise; however, additional long-term data is needed.

309

OUTCOMES AND COMPLICATIONS OF TRANS OBTURATOR TAPE (TOT): 1 YEAR FOLLOW UP

Kocjancic E.¹, Gherzi R.², Zaramella S.¹, Crivellaro S.¹, Favro M.¹, Ceratti G.¹, Gontero P.¹, Frea B.¹

¹Universitá del Piemonte Orientale, Department of Urology, Novara, Italy, ²Universitá del Piemonte Orientale, Department Of Gynecology, Novara, Italy

INTRODUCTION & OBJECTIVES: The Trans Obturator Tape (TOT) is a new technique, based on positioning of a tape under the middle urethra horizontally through the obturator foramina. The outcomes and complications of the TOT at 1 year follow up were evaluated.

MATERIAL & METHODS: 31 patients underwent to TOT for stress urinary incontinence (SUI) have been prospectively evaluated. In the first 6 patients was used the Uratape, a polypropylene tape covered by silicon in the middle part. Eventually, because of 2 cases of extrusion due to the silicon part, it was created and used the Obtape, the same tape without the silicon part. The patient was positioned in lithotomy position and a Foley catheter was inserted. A small (2 cm) incision was performed 1 cm below the external meatus in order to allow the digital dissection of the paraurethral. Through the skin the obturator foramen was identified and a small incision was done in the medial part just above the level of the urethral meatus bilaterally .Eventually a hooked tunneler was inserted through the incision at the level of the obturator foramen and the obturator fascia is perforated anteroposteriorly. The tunneler is than directed medially in the paraurethral space previously prepared and under direct digital control. The tape is inserted into the eye of the tunneler to retract the tape through the obturator foramina. The procedure is repeated on the other side. Patients were evaluated preoperatively, at 1, 6, 12 months of follow up with a physical examination, uroflowmetry, validated questionnaire (AUA score) and reported percentage of improvement.

RESULTS: The mean age was 62.9 (range 42 - 79). 84% (26/31) of the patients had genuine stress incontinence (GSI), 16% (5/31) had stress incontinence associated with urgency. The median follow up was 9 months (range 1-18 months). 81% (25/31) patients were dry one year after the surgery and 15% (5/31) were improved. The average of the AUA score has been decreased of 13 points (form 16 to 3) and the average percentage of improvement was 81 % up a maximum follow up of 18 months. Two cases of extrusion have been reported, using the Uratape, no cases of extrusion have been reported using the Obtape. In both cases of extrusion, the tape had been removed and the patients were continent after the procedure. One patient had developed new urgency. No significant changes in uroflowmetry parameters. One patient required the catheter for 15 days. The post residual volume, evaluated by ultrasound in each patient, was less than 50 cc.

CONCLUSIONS: The trans obturator tape is a simple, direct and quick procedure. It is associated with good outcomes and high patient satisfaction up to an average follow up of 9 months. Additionally the Obtape does not seem associate to erosion, extrusion or alteration of the normal voiding.

311

STRESS URINARY INCONTINENCE TREATMENT USING A SUB URETHRAL SUPPORT. RESULTS AT 1 YEAR FROM A MULTICENTRE PROSPECTIVE STUDY

Giolitto J.P.¹, Devoldere G.², Darcq E.³, Tournant G.⁴, Fendler J.P.⁵

¹Polyclinique les Bleuets, Department of Urology, Reims, France, ²Clinique Sainte Isabelle, Department of Urology, Abbeville, France, ³Clinique Saint Vincent, Department of Urology, Besancon, France, ⁴Clinique Saint Martin la Forêt, Department of Urology, Angers, France, ⁵Hôpital Saint Joseph - Saint Luc, Department of Urology, Lyon, France

INTRODUCTION & OBJECTIVES: To evaluate the efficacy and safety of Uretex® Urethral Support System for the treatment of Stress Urinary Incontinence via a multicentre prospective study.

MATERIAL & METHODS: The study included a consecutive series of 256 patients with mean age of 57 years [range 29-94 years], surgically treated for Stress Urinary Incontinence (SUI) between January 2001 and September 2002. A specially designed tension-free polypropylene mid-urethral support (Uretex® Sup - Sofradim) was used via a retropubic implant method. Concomitant procedures for a variety of prolapse conditions were performed in 43.4 % of study cases.

RESULTS: 56.6 % of patients received general anaesthesia, 41.4 % received spinal anaesthesia and 2.0 % received local anaesthesia. Peri operative complications were limited to 14 bladder perforations (5.4 %). No patients experienced blood loss greater than 300 cc. No vascular or nerve injuries were reported. During the follow up, no infection and no migration of the tension-free sling support were detected. Post operatively, reported events included 2 haematomas in the space of retzius (0.8 %), 13 urinary tract infections (5.1 %), 6 acute or persistent dysurias (2.3 %) necessitating sling section in one case at 7 days post procedure and in 5 cases at 3-18 months post procedure(in two cases minor urethral erosion were observed at the time of sling resection). All cases of dysuria were observed in the early phase of the study. 36 patients (14%) experienced temporary dysuria, all of which resolved within 2-3 months. 97.2 % of patients (249) have achieved one year follow up and were assessed at time of this report. At mean follow up of 16 months [range 8-31 months], 93.6 % of patients were cured or significantly improved. 16 patients (6.4 %) were considered failures, including 9 patients (3.6%) with urge incontinence. No pain related to sexual activity was reported.

CONCLUSIONS: Urethral support with the Uretex® Urethral support system is a safe and effective alternative to conventional sling and suspension procedures for SUI. These results favourably compare with those already published and need to be confirmed by long- term follow up.

313

VOIDING DYSFUNCTION AFTER TVT SLING

Mishra V.¹, Mishra N.², Karim O.¹, Motiwala H.¹

¹Wexham Park Hospital, Department of Urology, Slough, United Kingdom, ²Wexham Park Hospital, Department of Gynaecology, Slough, United Kingdom

INTRODUCTION & OBJECTIVES: The published literature so far has focussed mainly on the success and failure of TVT with regard to correcting stress incontinence and the reports of complications are few and far between. Our objective is to report the experience with our first 50 cases of TVT, specifically assessing voiding dysfunction after the procedure.

MATERIAL & METHODS: We carried out a retrospective study of all the 50 patients undergoing TVT surgery for urodynamically proven genuine stress incontinence between April '01 and June '03. The case-notes were reviewed to collect data on period of catheterisation, voiding and storage symptoms, their duration and management. The data were entered on a spreadsheet and analysed later.

RESULTS: Fifty women with a mean age of 54 years (36-77) were included in this study. They all had genuine stress incontinence on video-urodynamics. Seven (14%) patients reported preoperative voiding as well as storage symptoms. Twenty one (42%) patients had storage symptoms alone with or without detrusor overactivity on urodynamics, while 5 (10%) had detrusor overactivity on urodynamics but no storage symptoms. Postoperatively, urethral catheter was removed routinely within 12 hours. Twelve patients (24%) failed to void spontaneously and needed recatheterization. A third of them (4 patients) had their second urethral catheter removed successfully within a week. Of the remaining 8, 6 (50%) required a urethral or suprapubic catheter for variable lengths of time up to 3 months before resuming spontaneous voiding. Five of them continued to describe non-bothersome voiding symptoms for longer than 3 months. One patient (2%) continues on CISC and another one (2%) preferred to have her sling removed to doing CISC. Only one of these 12 patients had preoperative voiding symptoms. Twenty patients (40%) complained of storage symptoms postoperatively of whom 5 (25%) were cured within 3 months with (n=1) or without (n=4) anticholinergics. Of the remaining 15 patients (75%) whose symptoms lasted longer than 3 months, 2 (10%) were not bothered enough to seek any treatment and 11 (55%) benefited from anticholinergics with (n=2) or without (n=9) bladder drill. One patient (5%) who did not respond to these measures and another one (5%) who had her sling removed are awaiting further management. Of these 20 patients, 12 already had storage symptoms preoperatively, while TVT unmasked the symptoms in one patient who had detrusor overactivity on urodynamics but no storage symptoms preoperatively, leaving 7 (14%) patients who developed de novo urgency and/or urge incontinence. The management of these patients was no more difficult than that of those with pre-existing storage symptoms.

CONCLUSIONS: Voiding and storage symptoms following TVT sling are common but often transient and managed easily in a great majority (80-90%) of patients.

314

TENSION FREE VAGINAL TAPE (TVT) AND PERCUTANEOUS VAGINAL TAPE (PVT) FOR FEMALE STRESS URINARY INCONTINENCE: A COMPARATIVE STUDY

El-Azab A.S.¹, Rackley R.R.¹, Vasavada S.¹, El-Akkad M.A.², Tchetgen M.B.¹, Noble M.¹

¹The Cleveland Clinic Foundation, Urology, Cleveland, United States, ²Assiut University Hospital, Urology, Assiut, Egypt

INTRODUCTION & OBJECTIVES: TVT and PVT are minimally invasive procedures using prolene mesh placed at the midurethra for treating female Stress Urinary incontinence (SUI). The aim of the study is to evaluate the comparative effectiveness and safety of TVT and PVT.

MATERIAL & METHODS: 95 women with SUI were enrolled inaprospective nonrandomized study. Evaluation of the effectiveness was done by completing 4 validated questionnaires (Qr) before and 1 year after the procedure: Blaivas score, Global, IIQ-7, and UDI-6. Women were considered cured when they scored a 0 on the Blaivas. We assessed the non-inferiority of PVT to TVT with 1-tailed tests at 0.05 significance level testing the difference between means or proportions and using a delta value of 0.05 for proportion cured, and 20% of the scale for IIQ-7 (delta=3), UDI (delta=2) and global (delta=1). To evaluate safety, we recorded any intra or postoperative complications.

RESULTS: 95 patients were included in the study (32 with PVT and 63 with TVT). PVT is non-inferior to TVT using the IIQ-7 (P=0.05). Non-inferiority tests for Blaivas, UDI, and Global Qr were non-significant. 33 (56.9%) patients without prolapse were cured while 9 (42.8%) patients with prolapse were cured. The estimated difference in proportions for cure with and without prolapse was 14.04% (95% CI:-10.67, 38.75), P=0.27; there is no sufficient statistical evidence to support an association between prolapse and outcome. The estimated difference in proportions for cure with and without previous anti-incontinence surgery (AIS) was —5.56% (95% CI: -32.10, 20.99), P=0.68; there is no sufficient statistical evidence to support an association between previous AIS and outcome. 55% (17/31) patients with pure SUI and 52% (25/48) patients with Mixed Incontinence (MI) have been cured (P=0.81). 2 cases after TVT and 4 cases after PVT required urethrolysis.

CONCLUSIONS: Based on current sample size, PVT is not inferior to TVT in regard to efficacy using only IIQ-7 outcome. Our study is ongoing to get the desired sample size as determined by the biostatician before the beginning of the study.

316

RANDOMIZED CLINICAL TRIAL COMPARING SUPRAPUBIC ARCH SLING AND TENSION-FREE VAGINAL TAPE: SAFETY AND ONE-YEAR EFFICACY

Andonian S., Chen T., Corcos J.

Sir Mortimer B Davis Jewish General Hospital, McGill University, Department of Urology, Montreal, Canada

INTRODUCTION & OBJECTIVES: Suprapubic arch (SPARC) has been presented as comparable to Tension-free Vaginal Tape (TVT) but with no published studies. In order to test this new product we designed a randomized prospective clinical trial to compare them in term of safety and efficacy with a minimum follow up of one year.

MATERIAL & METHODS: Eighty-four consecutive female patients presenting with SUI were evaluated with history, quality of life (IIQ), physical examination and multichannel urodynamic studies (UDS). They were randomized to undergo SPARC or TVT procedure. Peri-operative information was obtained from standardized operative reports filled by the surgeon immediately post-operatively. In addition, anaesthesia and nursing reports were used. All patients were re-evaluated clinically at 1, 6 and 12 months post-operatively. Complete UDS and pad test were repeated at one year follow-up only.

RESULTS: Eighty-four women with SUI were recruited and consented for the study. Forty-one patients were randomized into the SPARC group and 43 into the TVT group. There was no statistical difference in between the two groups with regards to age, grade and type of SUI, and pad test. The mean pre-op pad test was 27.8 g and 29.3 g for the SPARC and TVT groups, respectively (2p= 0.86). There was no difference in mean OR time with 32.3min and 35.6min for SPARC and TVT groups, respectively (2p=0.51). The bladder perforation rate was the same in both groups with 10 patients in each group. The median estimated blood loss was the same for both groups (0-50cc). More patients in the TVT group 22 (51%) compared with the SPARC 13 (32%) required peri-operative analgesia during their hospital stay. The median hospital stay was the same for both groups with a median of one night. Complete retention was seen in 2 SPARC and 4 TVT patients. However, this was not statistically significant (x²=0.62; p≤1). Two in each group required re-operation to loosen the tape after 3 days. Other complications included: pelvic infection in a patient necessitating intravenous antibiotics and percutaneous drainage; Another patient developed fever on POD#1 and was treated medically. One case of SPARC erosion was treated with tape removal. At 12 months, 80% of SPARC patients and 89% of TVT patients were cured (x²=1; p≤1) Six patients in the SPARC group had a positive pad test with an average of 49.8g, while only 4 patients in the TVT group had a positive pad test with an average of 4.8g. However, there was no statistical significant difference in the Quality of Life questionnaire between the two groups (2p=0.5).

CONCLUSIONS: SPARC and TVT have similar peri-operative complications including hospital stay, bladder perforation, operative bleeding, and urinary retention. However, the two post-operative infections and tape erosion in one patient occurred in the SPARC group. Even though more patients in the TVT group were cured, this was not statistically significant at one-year follow-up.

318

6 YEARS EXPERIENCE WITH PUBOVAGINAL SLING USING CADAVERIC DERMAL GRAFTS (REPLIFORM) FOR STRESS URINARY INCONTINENCE

Crivellaro S.¹, Smith J.², Kocjancic E.¹, Bresette J.²

1Universita' Degli Studi Del Piemonte Orientale, Clinica Urologica, Novara, Italy, 2Lahey Clinic, Urological Department, Burlington, United States

INTRODUCTION & OBJECTIVES: We evaluated the safety and efficacy of using human dermal allograft material (Repliform) for pubovaginal slings in the treatment of female stress urinary incontinence (SUI).

MATERIAL & METHODS: We prospectively treated 234 patients with stress incontinence by anchor bone pubovaginal sling insertion using cadaveric human dermal allograft (Repliform). Complete clinical history was collected for each patient and a videourodynamic exam was performed preoperatively. The response to surgery for SUI was assessed by a third party through validated quality of life questionnaires (IIQ: incontinence impact questionnaire and UDI: urogenital distress inventory), pads use, overall impression (cured, improved, failure) and percentage of improvement as perceived by the patients. Scheduled follow-up exams have been performed to rule out erosion, pain, or recurrent incontinence.

RESULTS: Two hundred thirty-four patients were treated with allografts.33.7 % of the patients underwent to a previous prepubic procedure and at the urodynamic exam, Type III SUI was found in 48% of the patients. Average follow-up time was 18 months (range 1-54). SUI was improved or cured in 85% of patients. The median percentage of improvement was 80%. The average score of IIQ and UDI has been decreased respectively of 10 and 7 points at 18 months of follow-up. The average number of pads used a day was decreased from 3 to less than 1. Complications included new urgency (5%), recurrent SUI (15%), and retention (2%). One patient had transfusion requirements, and 5 patients needed ambulatorial removal of prolene suture. There were no cases of vaginal or urethral erosion, osteitis pubis, or osteomyelitis.

CONCLUSIONS: Our data indicates that use of human dermal allograft for pubovaginal slings is associated with low complication rates and no erosions. Additionally, efficacy appears to be good up to a maximum follow-up of 54 months.

340

LONG-TERM DUTASTERIDE THERAPY RESULTS IN CONTINUED IMPROVEMENTS IN SYMPTOMS AND PEAK URINARY FLOW IN MEN WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA

Debruyne F.¹, Barkin J.², Roehrborn C.³, on behalf of the ARIA3001, 3002 and ARIB3003 Study Investigators

¹University Hospital Nijmegen, Department of Urology, Nijmegen, The Netherlands, ²The Male Health Centres - CMX, Toronto, Ontario, Canada, ³The University of Texas South-Western Medical Centre, Department of Urology, Dallas, United States

INTRODUCTION & OBJECTIVES: Dutasteride, a dual inhibitor of Type 1 and Type 2 5a-reductase, improves symptoms and urinary flow, and reduces prostate volume, the risk of acute urinary retention (AUR) and the need for BPH-related surgery. This openlabel extension study provides 4 years of data to support the long-term efficacy and safety of dutasteride.

MATERIAL & METHODS: Patients who completed 2 years of randomised therapy with dutasteride (0.5 mg) or placebo were eligible for a 2-year optional open-label extension study. Entry criteria for the double-blind portion included age ≥50 years; prostate volume ≥30 cc; AUA-SI score ≥12; Q_max≤15 mL/sec; and PSA ≥1.5 ng/mL and <10 ng/mL. Efficacy measures were recorded at multiple time points. Results are presented from the open-label intent-to-treat population.

RESULTS: 4325 patients were randomised to dutasteride or placebo; 2340 patients received open-label dutasteride (1152 placebo/dutasteride [P/D], 1188 dutasteride/dutasteride [D/D]). Mean AUA-SI score and Qmax improved continuously in the D/D group over the 4-year study period. Changes from Month 24 to 48 were statistically significant (p<0.001 for symptoms, p<0.01 for Q_max). The P/D group treated with dutasteride between 24¨C48 months experienced improvements in AUA-SI and Qmax, but the improvements were not as great as patients receiving dutasteride for 4 years (p<0.001 for symptoms, p=0.042 for Q_max).

CONCLUSIONS: Long-term (4-year) treatment with dutasteride results in continuing improvements in symptoms and peak urinary flow. Earlier initiation of dutasteride therapy results in greater improvements from baseline at 4 years in symptoms and peak urinary flow compared with patients who were initiated on dutasteride therapy at 2 years.

341

LONG-TERM DUTASTERIDE THERAPY RESULTS IN SUSTAINED REDUCTIONS IN TOTAL PROSTATE VOLUME IN MEN WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA

Tammela T.¹, Barkin J.², Roehrborn C.³, On behalf of the ARIA3001, 3002 and ARIB3003 Study Investigators

¹Tampere University Hospital, Department of Urology, Tampere, Finland, ²The Male Health Centres, Suite 404, Toronto, Canada, ³The University of Texas South-Western Medical Centre, Department of Urology, Dallas, United States

INTRODUCTION & OBJECTIVES: Three randomised, placebo-controlled, 2-year Phase III studies have shown that the dual inhibitor of Type 1 and Type 2 5¦Á-reductase, dutasteride, improves symptoms and urinary flow, and reduces prostate volume, the risk of acute urinary retention (AUR) and the need for BPH-related surgery. This open-label extension study assessed the long-term efficacy and safety of dutasteride.

MATERIAL & METHODS: Patients randomised to 2 years of therapy with dutasteride (0.5 mg) or placebo were eligible for entry into the 2-year open-label extension study. Entry criteria at baseline for the double-blind portion included age ¡Ý50 years; prostate volume ¡Ý30 cc; AUA-SI score ¡Ý12; Qmax¡Ü15 mL/sec; and PSA ¡Ý1.5 ng/mL and <10 ng/mL. Efficacy measures were evaluated at multiple time points. Results are presented from the open-label intent-to-treat population.

RESULTS: 4325 patients were randomised to dutasteride or placebo; 2340 patients received open-label dutasteride (1152 placebo/dutasteride [P/D], 1188 dutasteride/dutasteride [D/D]). Patients in the D/D group experienced a mean decrease in DHT concentration of 90.2% from baseline to month 24, which was extended to 92.4% to month 48. Subjects in the P/D group had a 10.5% increase at month 24 and a 92.2% decrease at month 48. Total prostate volume (TPV) continued to decrease from baseline to month 48 for D/D-treated subjects (Table). TPV was reduced by a mean of 21.7% vs. baseline in P/D patients at 48 months, but did not reach the reduction observed at 4 years in D/D patients (-27.3%, p<0.001).

CONCLUSIONS: Long-term (4-year) treatment with dutasteride results in continued DHT suppression and sustained reductions in TPV. Earlier initiation of dutasteride therapy results in greater improvements in TPV from baseline at 4 years compared with patients who were initiated on dutasteride therapy at 2 years.

343

343 A PROSPECTIVE, COMPARATIVE STUDY OF THE ONSET OF SYMPTOMATIC BENEFIT OF DUTASTERIDE VERSUS FINASTERIDE IN MEN WITH BENIGN PROSTATIC HYPERPLASIA IN EVERYDAY CLINICAL PRACTICE

Hagerty J., Ginsberg P., Harkaway R.

Albert Einstein Medical Centre, Department of Urology, Philadelphia, United States

INTRODUCTION & OBJECTIVES: 5α-reductase inhibitors (5ARIs) have been shown to significantly improve lower urinary tract symptoms (LUTS) in men with symptomatic BPH and a prostate volume ≥30 cc. However, evidence from a number of studies demonstrates that the onset of significant symptomatic benefit with finasteride is typically 6 months following initiation. The objective of this prospective, observational study was to establish whether the dual 5ARI dutasteride, which inhibits both Type 1 and 2 5AR isoenzymes, has a different onset of symptom relief vs. the Type 2-selective 5ARI finasteride.

MATERIAL & METHODS: This prospective study recruited 240 consecutive men prescribed dutasteride (n=120) or finasteride (n=120) with benign prostatic enlargement and symptomatic BPH. Men entered into the study had a baseline prostate specific antigen (PSA) measurement and were told not to expect any symptomatic improvement for 6 months. American Urological Association Symptom Index (AUA-SI) score was assessed prior to, and following, 3 months of treatment.

RESULTS: At baseline, there were no significant differences in baseline age and serum PSA. After 3 months of therapy, patients had an improvement in AUA-SI score of between 0¨C3 points. Patients receiving dutasteride had significantly greater reduction in AUA-SI scores compared with those in the finasteride group: 36 (30%) vs. 22 (18%) had a 1 point improvement; 14 (12%) vs. 5 (4%) had a 2 point improvement; 2 (2%) vs. 1 (1%) had a 3 point improvement; and 68 (57%) vs. 92 (77%) had no change in their score. The estimated difference (and 95% C.I.) between the two treatment groups for the proportion of subjects with an improvement in AUA-SI is 20% (7.5%, 32.5%; two-sided Fisher's Exact test p<0.0016). Mean age and PSA were higher in men who had an improvement in AUA-SI score.

CONCLUSIONS: A significantly greater proportion of dutasteride-treated men experienced improvements in AUA-SI score at 3 months vs. finasteride-treated men.

344

BASELINE MEASURES AS PREDICTORS OF CLINICAL PROGRESSION OF BENIGN PROSTATIC HYPERPLASIA

Roehrborn C., MTOPS Research Group

The University of Texas South-Western Medical Centre at Dallas, Department of Urology, Dallas, United States

INTRODUCTION & OBJECTIVES: The decision to recommend a risk-reduction strategy for the treatment of benign prostatic hyperplasia (BPH) should be based upon an assessment of the patient's individual risk of progression. Data from the Medical Therapy of Prostatic Symptoms (MTOPS) Study placebo group was analyzed to determine if the relative risk of BPH progression, acute urinary retention (AUR), or need for BPH-related invasive therapy in untreated patients could be predicted from commonly available baseline measures.

MATERIAL & METHODS: In MTOPS, 737 patients were assigned to placebo and followed for an average of 4.5 years. Clinical progression of BPH was pre-defined as a ≥4-point increase in AUA SS, acute urinary retention (AUR), incontinence, renal insufficiency, or recurrent UTI. The need for BPH-related invasive therapy was a secondary outcome. Association of absolute risk with baseline levels of pre-specified covariates was assessed through regression models. The predictive value of baseline serum PSA was analyzed in detail. Receiver operator characteristic (ROC) curves were used to assess diagnostic test utility.

RESULTS: In placebo-treated patients, baseline PSA, Qmax, PVR, and prostate volume correlated significantly with the risk of BPH clinical progression and the need for BPHrelated invasive therapy (p=0.030 to <0.001). Baseline age also correlated with risk of BPH clinical progression (p<0.001) and AUA SS with invasive therapy (p=0.002). Baseline PSA and prostate volume also correlated with the risk of AUR (p=0.03 to 0.003). As shown in the table, the risk of BPH progression increased with increasing baseline serum PSA (p<0.001; R2=1.14%). The risk of AUR decreased as baseline serum PSA decreased (p=0.003; R2=4.41%). The risk of BPH related invasive therapy decreased as baseline serum PSA decreased (p=0.018; R2=1.45%). The area under the ROC curve for baseline PSA predicting clinical progression was 0.61, 0.70 for AUR, and 0.64 for BPH-related invasive therapy. Risk of BPH Progression, AUR, and BPH-Related Invasive Therapy, by Baseline PSA Tertile

*Number of events/100 participant years

CONCLUSIONS: Routinely available measures, including serum PSA, can predict a patient's future risk of BPH clinical progression, AUR, and BPH-related invasive therapy, permitting an informed decision concerning the value of medical therapy over watchfulwaiting.

350

TAMSULOSIN-TREATED PATIENTS HAVE A LOW RISK OF DEVELOPING ACUTE URINARY RETENTION WHICH IS WELL MAINTAINED OVER TIME

Speakman M.¹, Snijder R.², Doyle C.³

¹Taunton and Somerset Hospital, Urology, Taunton, United Kingdom, ²Yamanouchi Europe, Biostatistics, Leiderdorp, The Netherlands, ³Boehringer Ingelheim Pharmaceuticals Inc., Biostatistics, Ridgefield, United States

INTRODUCTION & OBJECTIVES: Results from the Medical Therapy on Prostatic Symptoms (MTOPS) study with a mean follow-up of 5 years demonstrated that both finasteride, the á1-adrenoceptor (AR) antagonist doxazosin and the combination reduced the risk of clinical progression and acute urinary retention (AUR) compared with placebo. Doxazosin delayed the time to progression of AUR and invasive therapy, but did not reduce the risk during the overall period. The effect of tamsulosin on AUR in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) was evaluated in a combined analysis of US and European trials.

MATERIAL & METHODS: Data from 12 European and US clinical trials with tamsulosin 0.4 mg or 0.8 mg once daily (6 placebo-controlled, 2 active controlled and 4 open-label extension studies) were combined in a pooled analysis to examine the effect of tamsulosin on AUR. A Kaplan-Meier survival curve was calculated for all patients on tamsulosin, indicating the time to the first episode of AUR. The observations were censored at the time a patient completed or withdrew from the last trial.

RESULTS: 2,543 patients with a mean exposure to tamsulosin of 696 days (range: 1- 2,356 days) were included in the analysis. The incidence of AUR per 100 patient years of exposure was 0.79. The Kaplan-Meier survival curve shows that the survival time to the first episode of AUR for patients on tamsulosin was long and that the risk of developing AUR did not increase over time (Figure).

CONCLUSIONS: Results from this pooled analysis demonstrate that patients treated with tamsulosin have a low risk of developing AUR, which is well maintained over time.

351

CONTINUATION OF ALFUZOSIN FOLLOWING CATHETER REMOVAL IN PATIENTS WITH ACUTE URINE RETENTION (AUR) RELATED TO BENIGN PROSTATIC HYPERPLASIA (BPH) REDUCES RISK OF AUR RELAPSE AND NEED FOR SURGERY

Hargreave T.¹, McNeill A.², Naadimuthu A.³, Beffy J.L.⁴, ALFAUR Study Group, Paris, France

¹Western General Hospital, Department of Oncology, Edinburgh, United Kingdom, ²Western General Hospital, Department of Urology, Edinburgh, United Kingdom, ³Sanofi-Synthelabo Research, Department of Clinical Research, Malvern, United States, ⁴Sanofi-Synthelabo Research, Department of Statistics, Malvern, United States

INTRODUCTION & OBJECTIVES: Urgent prostate surgery performed for AUR results in greater morbidity and mortality than the same surgery performed on an elective basis (Pickard 1998). Alfuzosin 10 mg administered for 2-3 days facilitated spontaneous voiding after removal of catheter, thereby avoiding the need for urgent surgery in the acute phase compared to placebo (p<0.05) (McNeill 1999 and McNeill 2003). The benefit of continuing alpha blockers in patients who successfully void after a first episode of AUR has not yet been documented in placebo-controlled trials. The follow-up phase of ALFAUR study investigated the interest of pursuing Alfuzosin treatment for 6 months after the initial AUR episode.

MATERIAL & METHODS: 169 patients with a first episode of AUR related to BPH who successfully voided after catheter removal at the end of first phase of ALFAUR were re-randomized to receive in a double-blind manner either Alfuzosin 10 mg OD or placebo for a further 6-month period. The primary efficacy criterion variable was the occurrence of need for surgery, including relapse of AUR.

RESULTS: The mean age of the patient population was 66.8 years; the mean catheterized volume at the time of the AUR episode was 946 mL and the mean post-void residual urine volume at the start of Phase 2 was 96 mL. During the 6-month treatment period, the incidence rates of need for surgery at months 1, 3 and 6 in the Alfuzosin treated patients were always lower with a relative risk reductions of 61% (p <0.05), 52% (p < 0.05) and 29% (p = 0.2), respectively, compared to placebo. Other BPH-related clinical parameters also improved and there were fewer visits to the urologists in the Alfuzosin group compared to the placebo group. The safety profile of Alfuzosin was excellent; no patients reported vasodilatory or coronary adverse events.

CONCLUSIONS: Continuation of Alfuzosin treatment beyond the acute phase of AUR related to BPH is of clinical interest in order to decrease the relapse of urinary retention and need for surgery.

508

NEW ANTIMUSCARINIC AGENT, SOLIFENACIN SUCCINATE, REDUCES URGENCY EPISODES IN OVERACTIVE BLADDER: AN ANALYSIS OF OVER 3000 PATIENTS

Chapple C.¹, Jonas U.², Chancellor M.³, Ridder A.⁴

¹Royal Hallamshire Hospital, Department of Urology, Sheffield, United Kingdom, ²Medizinizche Hochschule Hannover, Department of Urology, Hannover, Germany, ³University of Pittsburgh School of Medicine, Department of Urology, Pittsburgh, United States, ⁴Yamanouchi B.V., Leiderdorp, The Netherlands

INTRODUCTION & OBJECTIVES: Urgency is the defining symptom of overactive bladder (OAB) according to the recent clarification put forth by the International Continence Society; however urgency as an efficacy variable is rarely included in clinical trials. We report changes in the number of urgency episodes per 24 hours drawn from an analysis of 4 pivotal studies designed to evaluate efficacy and safety for solifenacin, a new antimuscarinic.

MATERIAL & METHODS: All studies were randomized, placebo-controlled, doubleblind trials with similar protocols and designs. Efficacy was based on 3-day micturition diaries and study duration was 12 weeks.

RESULTS: Evaluable patients included 1124 treated with placebo, 548 treated with solifenacin 5 mg, 1151 treated with solifenacin 10 mg, and 250 treated with tolterodine (2 mg bid) for a total population of 3073. Actual values for change from baseline to end point in mean number of urgency episodes per 24 hours were –2.9 for solifenacin 5 mg and –3.4 for solifenacin 10 mg as compared to a change of –2.0 for placebo and –2.1 for tolterodine. Treatment effects (active-placebo differences) were –1.12 and –1.48 episodes for the 5-mg and 10-mg solifenacin treatment arms, respectively, and both of these reductions were statistically significant (P<.001, ANCOVA with baseline as covariate). The treatment effect for the tolterodine arm (–0.64), although numerically smaller than values seen with solifenacin, also achieved statistical significance relative to placebo (P = .031). Responder analyses revealed that 62% to 66% of solifenacin-treated patients reported at least a 50% reduction in urgency episodes (relative to a baseline of approximately 6 episodes) at study end point; 55% of patients in the tolterodine arm reported a similar improvement of 50%. Subset analyses revealed that solifenacin was equally effective in reducing urgency episodes in men and woman. Similarly, reductions with solifenacin treatment were equivalent in elderly (³75) as well as younger patients (<65, ³65). Subgroups were also identified based on previous OAB drug treatment. Solifenacin produced reductions in the number of urgency episodes in patients for whom no previous OAB medication had been effective (–3.2 for 5 mg, –3.5 for 10 mg) that were equivalent to reductions in patients who reported efficacy with at least 1 previous medication (–3.4 for 5 mg, –3.3 for 10 mg). In contrast, reductions in urgency episodes seen with tolterodine-treated patients with a history of ineffective OAB pharmacotherapy were one half as robust as values seen in previous responders (–1.4 in previous nonresponders vs. – 2.7 in previous responders).

CONCLUSIONS: In an analysis involving over 3000 patients with symptoms of OAB, treatment with solifenacin was associated with statistically significant reductions in episodes of urgency. Improvements in urgency symptoms were independent of gender, age, and efficacy, or lack thereof, on previous drug therapy.

509

CLINICAL VALUE OF PERCEPTION OF INVOLUNTARY DETRUSOR CONTRACTION

De Wachter S., Van Meel T.D., Wyndaele J.J.

University of Antwerp, Department of Urology, Antwerp, Belgium

INTRODUCTION & OBJECTIVES: The efficacy of anticholinergic agents to reduce symptoms of an overactive bladder is variable and difficult to predict. This may be due to the presence of different pathophysiologic entities in overactive bladder syndrome. If present and demonstrable on cystometry, detrusor overactivity (DOA) can be qualified according to cause in neurogenic and idiopathic DOA, or according to pattern of occurrence in phasic and terminal DOA. This study evaluates whether the perception of involuntary detrusor contraction (IDC) may provide a parameter to classify patients with DOA.

MATERIAL & METHODS: Forty-five patients (23 women – 22 men, age 60 ±15 years) with overactive bladder symptoms and cystometrically verified DOA were studied. During cystometry, patients were asked to describe all sensations related to bladder filling. If an IDC was perceived as a sensation of bladder filling, DOA was classified as “DOA with sensation”. Excluded were patients with overt signs of neurologic impairment, bladder sensory threshold > 15 mA and positive ice water test. Parameters studied were: number of IDC, volume and amplitude of 1st IDC, amplitude of highest IDC and maximal cystometric capacity (MCC). Furthermore electrical sensory thresholds were determined in the bladder, proximal and distal urethra. In 24 patients the efficacy of anticholinergic treatment was evaluated. Treatment was defined as successful if frequency and episodes of urinary incontinence subjectively decreased.

RESULTS: Twenty-three patients did not perceive any of the IDC (“DOA without sensation”), whereas 22 perceived at least one IDC as a sensation of filling (“DOA with sensation”). Age and sex were not different between both groups (P > 0.1). Urodynamic parameters and sensory thresholds are compared in the table.

Treatment success with anticholinergics was higher in the group “DOA with sensation” (92%) compared to the group “DOA without sensation” (50%) (p=0.025).

CONCLUSIONS: Differences in cystometric parameters and sensory thresholds were shown between patients who did or did not perceive DOA as sensation of filling. Whether both types represent different entities or different grades of the same entity needs to be further studied. However, our preliminary data suggest that such classification might be clinically relevant as treatment outcome was significantly different in both groups.

510

ASSESSMENT OF RELIABILITY OF 1-DAY, 3-DAY AND 7- DAY FREQUENCY VOLUME CHARTS

Addla S.¹, Adeyoju A.¹, Neilson D.²

¹Stepping Hill Hospital, Department of Urology, Stockport, United Kingdom, ²Blackburn Royal Infirmary, Department of Urology, Blackburn, United Kingdom

INTRODUCTION & OBJECTIVES: Frequency Volume Chart (FVC) is one of the basic investigative tools in urological practice. This provides a good objective evidence of subjective symptoms. FVC’s have evolved over the past 25 years, from simple voiding charts to complex urinary diaries. Now, we not only record frequency and volume but also episodes of stress and urge incontinence, fluid intake and the patients’ activities in relation to their urinary symptoms. The ideal time period for a FVC remains unclear despite previous published studies. The objective of this study was to compare the relative reliability of FVC’s maintained for 1, 3 and 7 days using 9 parameters.

MATERIAL & METHODS: We studied 80 patients who were being investigated for nocturia and other lower urinary tract symptoms. Patients were requested to complete a FVC for 7 consecutive days. These FVC were then analyzed into three different groups – 1day (day1), 3 day (day2 to 4) and 7 day. The 1day FVC analysis included the first morning void on day 2. The analysis of 3 day FVC included the first morning void on day 5, similarly the 7-day FVC analysis included the first morning void on day 8. The 9 parameters included were daytime frequency, night time frequency, 24-hour frequency, daytime urine out-put, night time urine out-put, 24 hour urine out-put, maximum voided volume, nocturia index and Night time to Daytime diuresis ratio (N/D diuresis ratio).

RESULTS: The mean percentage difference between 1-day and 7-day FVC, 3 day and 7 day FVC for all parameters was 21.9 and 11.3 percent respectively. Among the clinically significant parameters, maximum mean difference between 7 day and 1 day was noted for N/D diuresis ratio (26.1%). However considering N/D diuresis ratio of 1.5 as a cut-off for diagnosing nocturnal polyuria only 9/80 in the 1-day group and 5/80 in the 3 day group had inconsistency in their diagnosis compared to 7 day analysis.

CONCLUSIONS: A properly performed 1-day FVC, which includes the first morning void the following day, is a reasonable tool to gain insight into the voiding habits during normal daily routine. 3 day FVC is adequate for accurate assessment of lower urinary tract symptoms and recommended for confirming a consistent clinical pattern and day-today practice. A 7-day FVC should be used in atypical clinical scenarios and for clinical research.

511

EFFECTS OF TOLTERODINE EXTENDED RELEASE IN PATIENTS WITH OVERACTIVE BLADDER: PERCEIVED TREATMENT BENEFITS IMPROVE WITH EFFICACY

Van Kerrebroeck P.E.¹, Wang J.², Guan Z.²

¹University Hospital Maastricht, Department of Urology, Maastricht, The Netherlands, ²Pfizer Inc, New York, United States

INTRODUCTION & OBJECTIVES: To evaluate the effect of tolterodine extended release (ER) 4 mg once daily on patients' perceptions of overall treatment benefit in patients with overactive bladder (OAB).

MATERIAL & METHODS: This was a 12-week, multicentre, double-blind, placebocontrolled study of tolterodine ER 4 mg qd in patients with symptoms of OAB (³8 micturitions/24 hrs, ³ 5 incontinence episodes per week, mean void £ 200 ml per micturition). Assessments were made at baseline and at week 12. A subanalysis of patients' perceived treatment benefit (none, little, much) versus objective (incontinence, pad use, volume voided, frequency) and subjective end points (urgency and bladder perception) was completed. Adverse events were recorded throughout the study.

RESULTS: After a 1-week washout, 508 and 507 patients, respectively, were randomized to placebo or tolterodine ER. Approximately 80% of patients were women with a mean age of 60 years. Other baseline demographic variables were comparable between treatment groups. After 12 weeks of treatment, significantly more patients on tolterodine ER perceived having much treatment benefit (43%) compared with those on placebo (24%, P<0.0001). Of the patients who perceived much treatment benefit, those receiving tolterodine had significantly greater improvement of objective and subjective end points compared with those receiving placebo (Table). The percentage of patients discontinuing treatment owing to adverse events, protocol violation, or lack of efficacy was similar between the two groups.

Patients who reported much treatment benefit, %

CONCLUSIONS: These data suggest that patient-perceived benefits of tolterodine ER treatment are associated with improved symptoms of OAB.

512

DARIFENACIN IS EFFECTIVE IN IMPROVING THE MAJOR SYMPTOMS OF OVERACTIVE BLADDER: A POOLED ANALYSIS OF PHASE III STUDIES

Chapple C.

Royal Hallamshire Hospital, Department of Urology, Sheffield, United Kingdom

INTRODUCTION & OBJECTIVES: To evaluate the efficacy, tolerability and safety of darifenacin, an M₃ selective receptor antagonist (M₃ SRA), in a pooled analysis of 3 multicentre, double-blind, placebo-controlled studies with identical inclusion criteria in patients with overactive bladder (OAB).

MATERIAL & METHODS: The pooled population comprised 1,049 adults (female 85%; 19-88 years) with OAB symptoms for >6 months. After a 2-week washout and 2- week placebo run-in, patients were randomised to 12 weeks' once-daily treatment with oral darifenacin controlled-release tablets 7.5 mg (n=335) and matching placebo (n=271) or darifenacin 15 mg (n=330) and matching placebo (n=384). Efficacy was evaluated using electronic diaries to record incontinence episodes and a range of secondary efficacy parameters (Table 1). Tolerability and safety were also determined.

RESULTS: Both doses of darifenacin were significantly superior to placebo in reducing incontinence episodes (Table 1). There was also a dose-response effect for patients achieving £50% reduction in incontinence episodes/week: 7.5 mg 66% and 15 mg 70% (p<0.001 vs. placebo). Significant improvement in all secondary efficacy parameters was also apparent vs. placebo (Table 1).

Table 1

Results are expressed as median (and %) change from baseline to week 12. *p<0.01, **p<0.001; using Hodges Lehman estimate.

The most common treatment-related AEs were dose-related dry mouth (7.5 mg 20%; 15 mg 35%; placebo 8%) and constipation (7.5 mg 15%; 15 mg 21%; placebo 6%) and together these resulted in low discontinuation rates (darifenacin 7.5 mg 0.6%; darifenacin 15 mg 2.1%; placebo 0.3%). CNS and cardiovascular (CV) safety were comparable to placebo at both doses.

CONCLUSIONS: Darifenacin, the first M₃ SRA, is well tolerated and provides significant improvement in the debilitating symptoms of OAB. Doses of 7.5 mg and 15 mg once daily are effective and well tolerated. Consistent with the M₃ selectivity profile of darifenacin, there were no CV safety concerns.
Supported by Novartis Pharma AG, Basel, Switzerland.

513

DARIFENACIN, AN M3 SELECTIVE RECEPTOR ANTAGONIST FOR THE TREATMENT OF OVERACTIVE BLADDER, DOES NOT AFFECT COGNITIVE FUNCTION IN ELDERLY VOLUNTEERS

Wesnes K.¹, Lipton R.², Kolodner K.³, Edgar C.⁴

¹Cognitive Drug Research Ltd, Chief Executive, Reading, United Kingdom, ²Albert Einstein College of Medicine, Epidemiology and Population Health, New York, United States, ³Advance Pcs, Hunt Valley, Maryland, United States, ⁴Cognitive Drug Research Ltd, Reading, United Kingdom

INTRODUCTION & OBJECTIVES: Antimuscarinics are the mainstay treatment for overactive bladder (OAB) but can cause CNS problems; e.g. cognitive impairment, somnolence etc., due to blockade of M₁ muscarinic receptors. OAB prevalence is high in the elderly, a population susceptible to drug-induced cognitive impairment and who may also have cognitive co-morbidities. This study determined whether darifenacin, an M₃ selective receptor antagonist (M₃ SRA), affected cognitive function in the elderly.

MATERIAL & METHODS: This double-blind, placebo-controlled, 3-period crossover study randomised 129 subjects (65–84 years; 58% female) to receive 3 of 5 treatments (darifenacin controlled release [o.d.] 3.75 mg, 7.5 mg, 15 mg or immediate release [t.i.d.] 5 mg) or matching placebo. Darifenacin IR was included for exploratory purposes and will not be discussed further in this abstract. Treatment periods were 14 days with a 7-day washout between treatments. Cognitive function tests (CFTs) were performed at the end of each treatment. Endpoint baseline differences were analysed using ANOVA. Although the study was powered to identify positive effects on cognitive function, the critical issue is whether antimuscarinics cause impairment.

RESULTS: Darifenacin had no effect on the 3 primary CFTs at any dose compared with placebo (see table). There were also no differences for secondary CFTs except for reduced memory scanning speed with darifenacin 3.75 mg vs. placebo, which was not dose dependent and probably due to statistical chance. The number of treatment relatedadverse events was similar across treatments, the most common being mild-to-moderate dry mouth and constipation.

Results expressed as baseline values with least squares mean change from baseline shown in parentheses. *p=0.04 vs placebo.

CONCLUSIONS: Darifenacin did not impair cognitive function in elderly volunteers. This may be explained by its M₃ selectivity, with low potential for M₁ receptor antagonism, the mechanism responsible for anticholinergic cognitive effects of other agents for OAB.
Supported by Novartis Pharma AG, Basel, Switzerland.

514

STUDY ASSESSING THE SAFETY AND EFFICACY OF THE PRO-ACT (ADJUSTABLE CONTINENCE THERAPY) FOR THE TREATMENT OF POST RADICAL PROSTATECTOMY INCONTINENCE: EFFECTS ON PATIENT'S QUALITY OF LIFE

Schlarp O., Huebner W.

Humanis Clinic Lower Austria, Department of Urology, Korneuburg, Austria

INTRODUCTION & OBJECTIVES: Current surgical management of post prostatectomy urinary incontinence can be invasive, costly and may require multiple lengthy procedures. There is a need for a minimally invasive treatment which has a positive effect on quality of life. The goal of our study was to evaluate the safety and impact on quality of life using the Pro-ACT system.

MATERIAL & METHODS: The Pro-ACT (Adjustable Continence Therapy) consists of two balloons placed contra laterally either at the level of bladder neck in post radical prostatectomy patients or external to the prostatic fossa at the level of the apex in patients with residual prostate tissue. Attached to each balloon via a tubing conduit is a titanium port placed in the scrotum which allows for percutaneous peri- and post operative adjustment to achieve and maintain continence. We report on the initial 77 patients. Baseline and follow up investigations included Quality of Life Questionnaires (I.Q.o.L.), urodynamics and pad usage. Balloon volumes were recorded at each post operative adjustment. Adverse events were noted.

RESULTS: Mean-Follow up to date is 14 months (1-300). Patients reported satisfactory improvements at 1 and 3 months. This trend continued at 6, 12 and 24 months.

Explantation for infection, migration or balloon rupture occurred in 16 patients. No serious adverse effects leading to long-term complications were reported. In 15 patients the Pro-Act System failed and they got the balloons explanted uneventfully. Of those 15 cases 13 received a hydraulic sphincter; one male sling was performed without any problem afterwards. In about one third of the patients sexual interest regained after being cured for stress urinary incontinence and asked for SKAT therapy or oral support medication.

CONCLUSIONS: Implantation of the Pro-ACT device is an intuitively easy procedure suitable for first line treatment incontinence following radical prostate surgery. Initial results show an improvement in continence over time. High positive impact on patient’s quality of life was noted.

516

BOTULINUM TOXIN INJECTIONS TO TREAT OVERACTIVE BLADDER

Schmid D.M.M¹, Schurch B.², John H.¹, Hauri D.¹

¹University Hospital Zurich, Department of Urology, Zurich, Switzerland, ²University Hospital Balgrist, Zurich, Paraplegic Centre, Zurich, Switzerland

INTRODUCTION & OBJECTIVES: Aim of this prospective study was to evaluate the efficacy of Botulinum A toxin (BTX) injections into the detrusor muscle to treat patients suffering from overactive bladder, refractory to anticholinergic drugs and physiotherapy.

MATERIAL & METHODS: 50 patients (25 m, 25 f; mean age 57 y., 29-82 y.) suffering from non-neurogenic overactive bladder (urgency-frequency syndrome) and incontinence despite administration of high doses of anti-cholinergics were treated by injections of 100-200 units of BTX into the detrusor muscle at 10-20 different sites under cystoscopic control. Micturition diary, full urodynamics, neurological status, urine probes and bladder biopsies were performed in all participants before treatment. Special attention was given to reflex volume (RV), maximal bladder capacity (MBC), detrusor compliance (DC), urgency and frequency/nocturia. Clinical and urodynamic checks were performed 6-8 weeks after treatment.

RESULTS: 40 patients (80%) with overactive bladder showed a significant (p<0.05) improvement of their bladder function in regard to subjective symptoms as well as to urodynamic parameters: Urgency and incontinence disappeared completely within 1-2 weeks after BTX-injections. Frequency decreased from 11.5 to 4.5 micturitions/day and nocturia from 4.5 to 1, respectively. MCB increased from mean 261 to 426 ml, DC rose from 26 to 45 ml/cmH2O and pre-treatment detrusor instability (RV mean 189 ml) dissolved. First-urge volume increased from mean 152 to 256 ml. There were no severe side effects except 2 temporary urine retentions. However, in 10 patients clinical benefit was poor and analysis revealed preoperative very low DC. Efficacy duration was mean 7 (+/- 2) months.

CONCLUSIONS: Our results show, that detrusor BTX injections may be an efficient and safe treatment option in patients suffering from overactive bladder refractory to all convenient treatments.

517

INVANCE MALE SLING FOR THE TREATMENT OF POSTPROSTATECTOMY INCONTINENCE: EARLY RESULTS AND COMPLICATIONS

González Martín M.¹, Alvarez Castelo L.¹, Giberti C.², Hubner W.³, Ilker Y.⁴, Kulaksizoglu H.⁵, Lehtoranta K.⁶, Schramek P.⁷

¹Juan Canalejo Hospital, Department of Urology, A Coruña, Spain, ²Ospendale San Paolo, Department of Urology, Savona, Italy, ³Krankenhaus Korneuburg, Department of Urology, Korneuburg, Austria, ⁴Marmara Universitesi, Department of Urology, Istanbul, Turkey, ⁵Uroloji Uzmani, Department of Urology, Bakirkoy-Istanbul, Turkey, ⁶Päijät- Häme Central Hospital, Department of Urology, Lahti, Finland, ⁷Prim Univ. Krankenhaus der Barmherzigen Bruder, Department of Urology, Vienna, Austria

INTRODUCTION & OBJECTIVES: To show an initial report of the clinical utility of the InVance Male Sling Kit in men with urinary incontinence after prostatectomy, following a multi-centre, non-randomized study conducted under a common protocol (AMS MES031).

MATERIAL & METHODS: All patients are males with urinary incontinence due to Intrinsic Sphincter Deficiency secondary to Trans Urethral Resection of the Prostate or radical prostatectomy. The surgical procedure is performed using the AMS InVance^TM Male Sling Kit, which consists of an Inserter, 6 bone screws, and a 4 x 7cm synthetic mesh. Under lithotomy position, a perineal incision is made, and dissection is carried out until bulbospongiosus muscle and descending pubic rami are exposed. 3 bone screws with polypropylene sutures are drilled into the medial aspect of each pubic ramus. Sutures are passed through the sling mesh, moved laterally to adjust tension over the urethra (verified with retrograde LPP) and tied. The measures of effectiveness are pad weights, patient and physician assessment of continence, and subject incontinence/quality of life (I-QOL) questionnaires, evaluated preop. and 4-6 weeks, 6 months, and 12 months after the procedure.

RESULTS: A total of 22 men, 54 to 82 year old (mean 69.7) underwent the placement of InVance sling. Etiology of incontinence was radical prostatectomy in 18 (81.8%) and TURP in 4 (18.2%). Preoperative urodynamics showed an average bladder capacity of 316 cc (105-540), mean VLPP 60.1 cm H2O and max. bladder pressure 24.7 cm H2O. Mean operative time is 83 minutes (45-136), with 60% general and 40 % spinal anaesthesia. At the time of abstract submission, 18 patients have 4-6 week follow-up evaluation, and 3 6-month assessment. 13 adverse events were reported in 5 patients, and 2 of them needed surgical revision: The first one 31 days after the implant, to replace 3 screws and drain a haematoma, and the second case 82 days after the implant to replace two dislocated screws. One patient had an acute myocardial infarction 24 hours postop. There were single patient adverse event reports of haematoma, urogenital pain and wound infection, and 2 cases of urinary retention after 5 days postop. I-QOL mean scores improved from 33.5 (±18.8) preop. to 69.1 (±23.6) 4-6 weeks postop. 59.1 % of patients had a preoperative 20 min. pad test weight gain ›20 gr, compared to 9.1% in the 4-6 week follow-up evaluation.

CONCLUSIONS: The InVance^TM male sling is a minimally invasive surgery which appears to be safe and effective for treating post-prostatectomy incontinence. Although further follow up is needed to establish the final efficacy of this procedure, early results show a low surgical revision rate (9% in our series) and moderate adverse events. Initial improvement of continence is obtained both in patient and physician assessment (66% completely dry or substantially continent), together with improvement in quality of life.

518

THE EFFECT OF TAMSULOSIN ON THE RESTING TONE AND THE CONTRACTILE BEHAVIOUR OF THE FEMALE URETHRA – A FUNCTIONAL URODYNAMIC STUDY IN HEALTHY WOMEN

Reitz A., Kyburz T., Knapp P., Wefer B., Schurch B.

Swiss Paraplegic Centre, Balgrist University Hospital, Department of Neuro-Urology, Zurich, Switzerland

INTRODUCTION & OBJECTIVES: This functional urodynamic study assessed the effect of the selective alpha 1A- blocker tamsulosin on the urethral pressure in healthy human females and hypothesised first that tamsulosin lowers the resting urethral pressure; second that tamsulosin influences the urethral contractility in response to magnetic stimulation of the sacral roots.

MATERIAL & METHODS: 11 healthy females gave their written informed consent and were included. A microtip pressure transducer catheter was inserted into the bladder and six baseline urethral pressure profiles were obtained. Another six urethral pressure profiles were recorded while magnetic single pulse stimulation of the sacral roots was performed above the motor threshold of the pelvic floor to evoke reproducible urethral contractions. Then the subjects received 400 microgram of tamsulosin and the entire protocol was repeated six hours after drug administration. Cardiovascular monitoring was obtained during the baseline and follow-up measurements. Mean and maximal urethral pressure values calculated over the entire urethra, mean pressure values calculated over the proximal, middle and distal third of the urethra and the pressure amplitudes to magnetic stimulation at baseline were statistically compared to the follow-up measurements with tamsulosin by ANOVA for repeated measures.

RESULTS: The oral administration of tamsulosin did not change the systemic blood pressure, but did significantly reduce the mean (p<0.01) and maximal (p<0.01) urethral pressure calculated over the entire urethra. When the proximal, middle and distal third of the urethra were analysed separately, there was a significant pressure reduction in the proximal (p<0.001) and middle (p<0.001) third of the urethral length while in the distal third there was no significant effect. Amplitudes of the urethral contractions evoked by sacral magnetic stimulation remained unchanged after tamsulosin.

CONCLUSIONS: These data show a functionally relevant effect of tamsulosin on the resting urethral tone in healthy females in vivo. Tamsulosin seems to act predominantly on the proximal and middle third of the female urethra and could offer a new pharmacological approach to treat urinary retention due to overactive or non-relaxing urethra in women.

519

BOTULINUM TOXIN URETHRAL SPHINCTER INJECTIONS TO RESTORE BLADDER VOIDING DYSFUNCTION

Schmid D.M.¹, Schurch B.², Hauri D.¹

¹University Hospital Zurich, Department of Urology, Zurich, Switzerland, ²University Hospital Balgrist, Zurich, Paraplegic Centre, Zurich, Switzerland

INTRODUCTION & OBJECTIVES: Aim of this prospective study was to evaluate the efficacy of Botulinum-A toxin (BTX) injections into the external urinary sphincter in patients with neurogenic and non-neurogenic bladder outlet obstruction (DSD, pelvic floor spasticity) or hypocontractile detrusor, who wish to void by valsalva manoeuvre.

MATERIAL & METHODS: 16 patients (11 m, 5 f; mean age 47 y; 10 non-neurogenic, 6 neurogenic) with voiding dysfunction (7 DSD, 5 pelvic floor spasticity, 4 hypocontractile detrusor) were treated by injections of 100 U BTX (Botox A, Allergan) into the urethral rhabdosphincter (at the 12, 4 and 8 o’clock positions) using a rigid cystoscope and a collagen injection needle. All underwent pretreatment urodynamics, neurological status, cystoscopy and urine probes and they filled out a micturition diary. Clinical and urodynamic checks were performed 6 weeks after treatment.

RESULTS: Postoperatively all 16 patients showed a significant improvement (p<0.05) of their voiding function regarding subjective symptoms (straining, micturition time, dribbling) and urodynamic parameters: maximum flow rate increased from mean 4.5 ml/s to 11.5 ml/s, whereas post-void residual decreased from mean 130 ml to 15 ml. The maximum micturition pressure decreased from mean 137 cmH2O to 63 cmH2O and the maximum urethral pressure at rest diminished from 131 cmH2O to 75 cmH2O. 4 patients who did intermittent catheterization were able to void spontaneously after BTXtreatment. No side effects such as stress urinary incontinence or general paralysis occurred. Duration of the effect was mean 6 (+/- 2) months.

CONCLUSIONS: Urethral sphincter BTX injections in male and female patients with complex voiding dysfunction are an encouraging efficient and safe alternative treatment to failing antispastic oral treatment.

522

PROPIVERINE VERSUS TOLTERODINE – EFFICACY AND TOLERABILITY IN PATIENTS WITH DETRUSOR OVERACTIVITY

Jünemann K.P.¹, Halaska M.², Rittstein T.³, Brünjes R.⁴

¹University Hospital Kiel, Department of Urology, Kiel, Germany, ²University Prague, Department of Gynaecology, Prague, Czech Republic, ³Nemocnice Kladno, Department of Gynaecology, Kladno, Czech Republic, ⁴APOGEPHA, Dresden, Germany

INTRODUCTION & OBJECTIVES: Comparison of the efficacy, tolerability and of the impact on quality of life of propiverine (prop) and tolterodine (tolt) in the treatment of patients with idiopathic detrusor overactivity.

MATERIAL & METHODS: In a randomised, double-blind, multicentre clinical trial patients with idiopathic detrusor overactivity were treated with 15 mg prop b.i.d. or 2 mg tolt b.i.d. for 28 days. The maximum cystometric capacity was determined at baseline and after 4 weeks of therapy. The difference of both values was used as primary endpoint. Secondary endpoints were voided volume per micturition, efficacy evaluation by the investigator, tolerability, post void residual, and quality of life measured by the King’s Health Questionnaire Score.

RESULTS: The per-protocol population included 155 patients (prop: 75, tolt: 80; age: 56.3 +/- 14.9 years, female: 128 (82.6%)), the intention-to-treat population 201 patients (prop: 100, tolt: 101; age: 56.3 +/- 14.9 years, female: 158 (78.6%)) and the safety population 202 patients. Efficacy: In the per-protocol population the mean maximum cystometric capacity increased significantly (p<0.01) in both groups. For prop there was an increase from 209.2 +/- 64.5 to 265.1 +/- 112.2 ml (+55.8 +/- 116.2 ml). For tolt there was an increase from 202.6 +/- 67.1 to 272.6 +/- 116.1 ml (+70.1 +/- 101.3 ml). Both groups were comparable (p = 0.42). This was confirmed by the median values (prop +44.0 ml; tolt +47.5 ml). The voided volume per micturition increased by 31.4 +/- 60.8 ml in the prop group, and by 27.7 +/- 56.3 ml in the tolt group. In the final efficacy evaluation the investigators judged prop as very good or good in 60 %, moderate in 24 %, and insufficient in 15 % of the cases. Tolt was judged as very good or good in 58 %, moderate in 23 %, and insufficient in 19 % of the cases. Tolerability and safety: 42/100 patients in the prop group and 43/102 in the tolt group experienced adverse events. The most common adverse event, dry mouth, occured in 20 patients in the prop group and in 19 patients in the tolt group. 16 premature study terminations were documented. In both groups 6 of these terminations were caused by adverse events. No relevant changes in post void residual were observed. The scores for the quality of life improved comparably in both groups (prop: from 53.7 to 45.4; tolt: from 52.0 to 44.6).

CONCLUSIONS: This study demonstrates for the first time comparable efficacy, tolerability, and improvement in the quality of life of 15 mg prop b.i.d. and 2 mg tolt b.i.d. in the therapy of the symptoms of detrusor overactivity.

558

RESULTS OF A PROSPECTIVE STUDY IN 110 PATIENTS WITH LOWER URINARY TRACT SYMPTOMS (LUTS) CAUSED BY BENIGN PROSTATIC HYPERPLASIA (BPH) USING A NITINOL THERMO-EXPANDABLE BELLSHAPED PROSTATIC STENT

Van Dijk M., Mochtar C., Laguna P., De Reijke T., De La Rosette J.

AMC University Hospital, Department of Urology, Amsterdam, The Netherlands

INTRODUCTION & OBJECTIVES: To assess the efficacy and durability of a second generation thermo-expandable temporary prostatic stent in patients with LUTS due to BPH.

MATERIAL & METHODS: From July to November 2002 a total of 110 men with LUTS due to BPH were included. A second generation bell-shaped temporary nitinol stent was used and delivered under topical anaesthesia and direct vision with a 26 Ch. gun-shaped delivery system. Five different sizes (3.5-5.5 cm) were used based on the length of the prostatic fossa. Morbidity, efficacy, durability and complication rates were measured including symptom scores and uroflowmetry parameters at baseline and at 1, 4, 12, 26 and 52 weeks after insertion of the stent.

RESULTS: In 3 patients the stent insertion failed because of anatomical limitations or bad deployment of the stent. All patients tolerated the placement very well and did not need any additional pain medication. Minimal temporary haematuria was observed in the majority of patients whereas an immediate significant objective and subjective improvement was measured. Because of clot retention early removal was necessary in 3 men. The migration rate towards the bladder was significantly less when compared with the first generation nitinol stent. At 1 week, 4 weeks, 12 weeks, 26 weeks and 52 weeks, a total of 98, 93, 57, 41 and 36 stents respectively were still in situ. The main reason for stent removal was worsening of symptoms and flow caused by tilting (thus causing obstruction) of the stent in the prostatic fossa. At present 33 stents are still in situ. Minimal encrustation of the stent was observed in most patients not causing any problems. Stent removal was under topical anaesthesia and uneventful in almost all of the cases. Four stents needed to be removed under general anaesthesia.

CONCLUSIONS: The self-expandable bell-shaped nitinol prostatic stent results in a significant temporary improvement during the first 2-3 months after insertion with minimal stent migration. The phenomenon of tilting of the stent requires removal, resulting in a durability of one third of the cases at 1 year follow up.

564

CORRELATIONS BETWEEN PROSTATE VOLUME REDUCTION AND CLINICAL VARIABLES AFTER MICROWAVE THERMOTHERAPY

Mattiasson A.¹, De la Rosette J.², Laguna P.², Gravas S.², Schelin S.³, Wagrell L.⁴, Graber S.⁵

¹Lund University Hospital, Department of Urology, Lund, Sweden, ²Academic Medical Centre, Department of Urology, Amsterdam, The Netherlands, ³Specialistläkargruppen, Department of Urology, Kalmar, Sweden, ⁴Uppsala University Hospital, Department of Urology, Uppsala, Sweden, ⁵Kantonspital, Department of Urology, Aarau, Switzerland

INTRODUCTION & OBJECTIVES: Microwave thermotherapy for treatment of BPH has developed from being a treatment resulting in mainly vague symptomatic improvement in the early nineties, to a treatment resulting in tissue ablation and improvement in symptomatic as well as objective variables with the modern devices. The present analysis was performed in order to investigate possible correlations between prostate volume reduction and improvements in clinical variables after microwave thermotherapy with ProstaLund Feedback Treatment® (PLFT®), using the CoreTherm® device.

MATERIAL & METHODS: The results of a total of 180 patients, from three prospective clinical studies, utilizing the same study protocol and assessing the clinical efficacy and safety of ProstaLund Feedback Treatment, were pooled together. All patients had benign prostatic hyperplasia (BPH) and were followed up 12 months post treatment. Study variables included International Prostate Symptom Score (IPSS), bother score, peak flow rate (Q_max), voiding pressure and prostate volume reduction determined by transrectal ultrasound (TRUS). RESULTS: Improvements were achieved both for subjective and objective variables (see table, mean and S.D.). Significant correlations were observed between prostate volume reduction and change in Q_max (r=0.34, p<0.001) and change in voiding pressure (r=-0.21, p=0.010). In accordance, a significant correlation was also observed between prostate volume reduction and change in Abrams-Griffith score (r=-0.26, p<0.002). Furthermore, the prostate volume reduction showed a significant correlation with the tissue necrosis calculated on-line during treatment (r=0.46, p<0.001).

CONCLUSIONS: This analysis suggests that the clinical outcome after microwave thermotherapy with PLFT is correlated to the obtained prostate volume reduction after treatment. Furthermore, tissue necrosis, calculated by the PLFT software during treatment, can be used as a tool to predict the prostate volume reduction.

565

TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE (TUNA) - IS IT A DURABLE OPTION?

Phillips J., Rosario D., Hazell J., Chapple C.

Royal Hallamshire Hospital, Department of Urology, Sheffield, United Kingdom

INTRODUCTION & OBJECTIVES: Transurethral needle ablation (TUNA^TM) of the prostate is a minimally invasive technique for the treatment of symptomatic benign prostatic obstruction (BPO). Whilst safe and providing significant symptomatic improvement in the short-term, there is little published evidence on its long-term benefit. The aim of this study was to re-evaluate the outcome seven years after TUNA^TM in a cohort of men with documented BPO at the outset.

MATERIAL & METHODS: Seventy-one men who had previously undergone TUNATM more than seven years previously were re-evaluated using clinical outcome, IPSS symptom score, uroflowmetry, and residual urine estimation. The median follow-up period was 102 months (range 92 - 105 months). Treatment failure was defined as those patients who required further intervention to control lower urinary tract symptoms.

RESULTS: Of the original 71 patients, 10 (14%) died from unrelated causes during the follow-up period. 35 patients (49%) have undergone further surgery, which included TURP (n=32), BNI (n=2), or thermo-ablation (n=1). The median time to symptom recurrence for this group was 12 months. Of those remaining, 14 patients continue to be satisfied with their symptoms (QLA score 0-2), of which 7 are concomitantly on alphareceptor antagonists. 24 men had received either alpha-blockade only or no further intervention after 7 years, of whom 15 (62.5%) returned for full re-assessment. All of these were obstructed on uroflowmetry, regardless of their symptom status.

CONCLUSIONS: Whilst TUNA^TM provides early symptomatic relief in the majority, it does not appear to provide durable long-term symptomatic improvement, and should not be recommended as a standard treatment option for symptomatic BPO.

566

IMPACT OF HOLMIUM LASER ENUCLEATION (HOLEP) VERSUS TRANSURETHRAL RESECTION (TURP) OF THE PROSTATE ON SEXUAL FUNCTION: RESULTS OF A PROSPECTIVE MULTICENTRIC RANDOMIZED TRIAL

Briganti A.¹, Naspro R.¹, Vavassori I.², Suardi N.¹, Salonia A.¹, Mazzoccoli B.¹, Rigatti P.², Montorsi F.¹

¹Scientific Institute H. San Raffaele, Department of Urology, Milan, Italy, ²Cliniche Gavazzeni, Department of Urology, Bergamo, Italy

INTRODUCTION & OBJECTIVES: This study was aimed at investigating clinical sexual function outcome in patients affected by Benign Prostatic Hyperplasia (BPH) undergoing either Holmium laser enucleation (HoLEP) or trans-urethral resection (TURP) of the prostate.

MATERIAL & METHODS: Between January and December 2002 100 patients (mean age ±SD: 64.6±7.3 yrs; range 49-79) affected by BPH have been enrolled in this study. 52 out of 100 patients (mean age ±SD: 65.14±7.1 yrs) underwent HoLEP (Group 1) and 48 (mean age ±SD: 64.5±7.4 yrs) underwent TURP (Group 2), p=0.9. Baseline assessment, follow-up at 3 and 6 months based on sexual and medical history; physical examination, total serum PSA, trans-rectal ultrasound, uroflowmetry and International Index of Erectile Function (IIEF) were performed. Statistical analysis has been performed by means of the Student’s t test and Chi-Square Test. Data are shown as mean ±SD.

RESULTS: None of the 100 patients affected by BPH presented any pre-operatively anatomic alteration of the penis assessed at the physical examination. IIEF Erectile Function Domain (Group 1 vs. Group 2). Baseline: 21.4±3.1 vs. 22.3±3.6 (p=0.5); Three months follow-up: 23.5±3.6 vs. 23.4±3.5 (p=0.67); Six months follow-up: 23.8±3.9 vs. 24.1±3.7 (p=0.55).IIEF Orgasmic Function Domain (Group 1 vs. Group 2). Baseline: 8.5 ±2.1 vs. 8.7±1.9 (p=0.5); Three months follow-up: 6.5±1.2 vs. 5.9±1.1 (p=0.67); Six months follow-up: 6.5±1.3 vs. 6.3±1.1 (p=0.71). The statistical analysis shows a significative difference concerning IIEF Orgasmic Function Domain between pre and post-operative data both in TURP (p<0.001) and in HoLEP (p<0.001) groups.

CONCLUSIONS: Our data show no significative differences in post-operative IIEF Erectile and Orgasmic Function Domain between patients undergoing either TURP or HoLEP. Both TURP and HoLEP seem to determine significative alteration of IIEF Orgasmic Function Domain between pre and post-operative time.

567

HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) VERSUS OPEN PROSTATECTOMY FOR PROSTATES >70 GR: SHORT TERM FOLLOW-UP

Naspro R., Mazzoccoli B., Suardi N., Salonia A., Deho' F., Di Girolamo V., Colombo R., Guazzoni G., Rigatti P., Montorsi F.

University Vita-Salute, Scientific Institute H. San Raffaele, Department of Urology, Milan, Italy

INTRODUCTION & OBJECTIVES: To compare intra and peri-operative outcomes and follow-up after holmium laser enucleation (HoLEP) or standard open prostatectomy for the treatment of benign prostatic hyperplasia (BPH) of prostates >70 gr.

MATERIAL & METHODS: From March to August 2003, 40 consecutive patients with symptomatic BPH and a prostatic weight >70gr were prospectively randomised to be treated surgically either with HoLEP (group 1, n=20) or standard open prostatectomy (group 2, n=20). Patients of both groups were pre-operatively assessed by scoring of subjective symptoms with International Prostate Symptom Score (I-PSS) and Quality of life (QoL) questionnaires, physical exam including digital rectal examination, total serum PSA level, kidney-bladder and trans-rectal prostatic ultrasonography. Total time in the operative room, time of morcellation, total grams of tissue removed, pre-operative and post-operative serum haemoglobin levels, time of catheterization, of hospital stay and histologic diagnosis were also assessed. Patients were evaluated at 1 and 3 month followup with the same tests

RESULTS: The mean pre-operative trans-rectal ultrasound volume of the prostates was (mean±SE) 108.15±30.5 gr and 116.7±24.02 gr (p=0.33) and volume of the adenoma was (mean±SE) 75.8±34.5 gr and 82.5±4.5 gr (p=0.41), in the HoLEP and open prostatectomy groups respectively. Pre-operative total PSA values (mean±SE) were 5.8±3.01 ng/dl and 6.9±2.89 ng/dl (p=0.29), in the HoLEP and open prostatectomy groups respectively. Time of the operation was overall longer in the HoLEP group (62.9±18.3 mins vs. 53.5±11.5 mins, p=0.06), whilst catheter removal (1.5±1.07 days and 4.1±0.5 days) and hospital stay (2.7±1.07 days vs. 5.4±1.05 days, p<0.001) were significantly shorter in the HoLEP group compared to open prostatectomy. The mean weight of the specimens was 28.3±3.3 gr and 12.6±2.04 gr (p=0.005) in the HoLEP and open prostatectomy groups respectively. Day 1 post-operative haemoglobin levels were 12.3±1.8 g/dl vs. 11.1±1.64 g/dl (p=0.04) in the HoLEP and open prostatectomy groups respectively. Twelve patients from the open prostatectomy group required blood transfusion compared to four from the HoLEP group (p<0.07). At 1 and 3 month follow up no statistical difference was seen between the two groups at uroflowmetry, at IPSS and QoL. At 3 months follow up, 3 patients still complained of a mild stress incontinence in the HoLEP group and 2 from the open prostatectomy group, and two patients from the HoLEP group underwent re-intervention for prostatic fossa revision. No incidental adenocarcinoma of the prostate was diagnosed in the HoLEP group whilst 3 cases were observed in the open prostatectomy group.

CONCLUSIONS: HoLEP for treatment of BPH with prostates >70 gr seems a feasible technique guaranteeing similar results to open prostatectomy. However, the reduction in catheterization, hospital stay and blood loss make HoLEP an attractive endourologic option for the treatment of larger prostates

568

PROSPECTIVE STUDY OF FLUID ABSORPTION IN TURP & HOLEP USING ETHANOL TAGGED IRRIGANT FLUID & SERUM SODIUM ESTIMATION

Bapat S.¹, Umranikar S.¹, Satav V.¹, Bapat A.¹, Joshi A.², Ranade G.²

¹Maharashtra Medical Foundation, Joshi Hospital, Department of Urology, Pune, India, ²Maharashtra Medical Foundation, Joshi Hospital, Department of Anaesthesiology, Pune, India

INTRODUCTION & OBJECTIVES: To detect and compare occurrence and volume of fluid absorbed during Holmium enucleation of prostate (HoLEP) and conventional TURP using ethanol (1%w/v) tagged fluid and Serum Sodium (S. Na.) concentration.

MATERIAL & METHODS: This prospective study comprised of 50 patients of symptomatic BPH of which 26 underwent TURP and 24 HoLEP. It was conducted after Ethics Committee approval & informed consent. All patients were investigated as per the institutional protocol. Patients were matched for age and other parameters. Irrigation fluid was sterile water, tagged with ethanol (1%w/v). Procedure was performed under spinal (10) or epidural (40). Intra-operative vitals and expired breath ethanol using alcohol breathalyser were monitored at 10-minute intervals. Sr. Na. estimations were done pre & postoperatively. Volume resected and total resection time was noted. Results were analysed statistically using standard nomograms. Majority of patients (45/50) were operated by a single operator.

RESULTS:

CONCLUSIONS: Fluid absorption was detected in 32/50 patients (HoLEP – 10/24 & TURP – 22/26). Of the 18 patients with no absorption, 14 underwent HoLEP. Volume of absorbed fluid in HoLEP was very small. This study conclusively proved that HoLEP is associated with mild to negligible fluid absorption and low risk of TUR syndrome. Quantification of fluid absorption was very easy and more accurate with alcohol breathalyser.

569

DAY CASE HIGH-POWER KTP LASER VAPORIZATION OF THE PROSTATE – INITIAL EXPERIENCE

Barber N., Zhu G., Donohue J., Thompson P., Walsh K., Muir G.

King's College Hospital, Department of Urology, London, United Kingdom

INTRODUCTION & OBJECTIVES: The ‘Green light’ PVP system (Laser scope UK) delivers an average of 80W power and results in rapid and efficient vaporization of the prostate in an almost bloodless environment, thanks to the unique properties of the KTP laser employed. Primarily we report on the safety and effectiveness of this new procedure in the first 30 patients, with 6 months follow up. We will also discuss the exciting possibilities offered by ‘Green light’ PVP having operated on over 100 patients at our institution.

MATERIAL & METHODS: 30 patients on the routine waiting list for TURP were offered this new procedure (mean age = 66yrs) (mean prostate volume 60ml – 9 patients). All procedures were performed under general anaesthetic in the day surgery unit, using a 22Ch continuous flow cystoscope and sterile water as the irrigation fluid. 80W of KTP laser energy was delivered in the non-contact mode via a side firing ADD Stat laser fibre (Laser scope UK) under direct vision. Following protocol, the first 20 patients had an 18Ch 2-way catheter at the end of the procedure. The placement of a catheter in the next 10 patients was at the surgeons’ discretion. All catheters were to be removed 15 hours postop. The first 10 patients stayed one night in hospital for observation, all except 2 of the next 20 patients were discharged home within 4 hours of the procedure.

RESULTS: No patient required post operative irrigation and 90% voided successfully on initial removal of catheter. 3 of the last 10 patients voided successfully and were discharged directly from the day unit having not had a post operative catheter sited. At 6 months results indicate significant improvement in lower urinary tract symptoms from preoperative figures in terms of mean IPSS (22.4 to 7), Quality of Life score (4.6 to 1.3), Max. flow rate (8.3 to 19.5 ml/s) and post void residual volume (117.5 to 29 mls). Erectile function as quantified by the IIEF-5 score was, on average, unchanged at 6 months and of those sexually active (n = 18), 55% described retrograde ejaculation. Complications included bladder neck stricture (7%) and urinary tract infection (7%). Post operative estimation of prostate volume in 5 patients demonstrated a 48% mean decrease.

CONCLUSIONS: High power KTP laser vaporization of the prostate is safe, effective and can be performed in the day case setting with rapid discharge. Furthermore, in selected cases the procedure may be catheterless. Results at 6 months demonstrate sustained improvements in lower urinary tract symptoms with maintenance of erectile function and transrectal ultrasound estimations indicate substantial tissue removal. Our further experience has demonstrated similar efficacy of this procedure in very large

570

80W HIGH-POWER KTP LASER VAPORIZATION OF THE PROSTATE. CLINICAL RESULTS AFTER 110 CONSECUTIVE PROCEDURES

Bachmann A., Wyler S., Ruszat R., Casella R., Gasser T., Sulser T.

University Basel, Department of Urology, Basel, Switzerland

INTRODUCTION & OBJECTIVES: To study the clinical feasibility and efficiency of 80W KTP laser vaporization of the prostate in patients with symptomatic benign prostatic hyperplasia (BPH) and prostatic carcinoma (PCA).

MATERIAL & METHODS: Up to date 110 patients underwent the operation utilizing the photo selective potassium titanyl phosphate (KTP) laser vaporization with a 80W power setting. All consecutive patients, independent of a history of chronic urinary retention or chronically indwelling catheter were included. The clinical evaluation included transrectal ultrasound, residual urine volume (Vres) measurement, International Prostate Symptom Score (IPSS) and urinary peak flow rate (Qmax). A follow-up of 6 months is presented.

RESULTS: In all 110 patients KTP laser vaporization was performed successfully. Twelve (11%) patients with known PCA were treated. Mean age was 72±10 yrs. (46-95 yrs.). 42% (n=47) of our patient population had an indwelling transurethral catheter and 6% (n=6) a suprapubic catheter at time of admission to the hospital. Mean prostate volume was 49±26 ml (15-250 ml) and mean operating time was 56±26 min (10-160 min.). No major complication occurred intra- or postoperatively, especially no intra- or postoperative transfusion, TUR-syndrome, fistula or capsule perforation. The indwelling catheter was removed on average day 1.8±1.2 (1-6 days) after operation. Overall 18 patients (16%) were discharged with a transurethral or suprapubic catheter. Up to date in all patients the catheter has been removed within 1 month after operation. IPSS (mean) decreased from preoperatively 18.7 to 11.4, 10.3, 7.4 and 6.3 at time of discharge, 1, 3 and 6 months follow-up, respectively; Qmax (mean) increased from 10.9 ml/s preoperatively to 13.0, 19.5, 18.4 and 21.1 at time of discharge, 1, 3 and 6 months followup; Vres (mean) decreased from 183ml preoperatively to 86.9, 26.3, 19.7 and 28.7 at time of discharge, 1, 3 and 6 months follow-up, respectively. Up to date no reoperation was necessary.

CONCLUSIONS: Our short-term results are very encouraging and demonstrate that 80W high-power KTP laser vaporization is safe and efficient for men with symptomatic BPH. With the 80W KTP laser characteristics an instantaneous debulking of prostate tissue is obtained with a reliable relief from obstructive voiding symptoms. Long-term follow up is in progress and is hoped to confirm these results.

571

A PROSPECTIVE RANDOMISED STUDY BETWEEN TRANSUREHTRAL VAPORISATION USING PLASMAKINETIC ENERGY AND TRANSURETHRAL RESECTION OF PROSTATE: THREE YEAR FOLLOWUP

Chandrasekar P., Kapaasi F., Virdi J.

Princess Alexandra Hospital, Department of Urology, Harlow, Essex, United Kingdom

INTRODUCTION & OBJECTIVES: To study the efficacy and safety of Plasma kinetic^TM energy using Gyrus electrosurgical system against standard resection of using monopolar energy in the treatment of benign prostatic hyperplasia.

Randomisation was commenced in October 1998 with ratio of 2:1 (Plasma kinetic: TURP). Seventy six (22 with retention of urine) so far has been enrolled in this study with age ranging between 50 to 82 (mean 70.1) years and prostatic weight 20 to 105 (mean 48.3) grams. Fifty-one patients underwent vaporisation and 25 treated by standard transurethral resection. Intra operative parameters were operating time, blood loss (Haemocue B haemoglobin system), fluid absorption during TURP by using ethanol glycine by alcoholmeter (saline was used during vaporisation), serum sodium and haemoglobin. No post- operative irrigation was used and catheter was removed at 36 hours.

RESULTS:

Results are expressed in Mean ±SD   p value < 0.001

Operative duration was similar in both the groups. There was no significant difference in pre and post-operative sodium and creatinine. Mean blood loss in plasma kinetic group was 251ml (range 49-1000)and TURP group 497ml (range50-1750).Fluid absorption in TURP group was <500ml. One patient in plasma kinetic group had prolonged catheterisation for five days, 3 patients had mild stress incontinence lasting three months and 2 patients required TURP.

CONCLUSIONS: Plasma kinetic vaporisation produced reduced intra operative bleeding and has no risk of TUR syndrome due to saline irrigant. This technique is simple to learn, offers safety with no added morbidity.

663

EFFICACY, SAFETY, AND DOSAGE OF ENGLISH BOTULINUM TOXIN-A IN NEUROGENIC DETRUSOR OVERACTIVITY

Del Popolo G., Li Marzi V., Lombardi G.

Careggi Hospital, Department of Neuro-Urology, Florence, Italy

INTRODUCTION & OBJECTIVES: Botulinum Toxin type A (BTX-A) has utilized in urologic field to treat spinal cord injured pts (SCI) with detrusor overactivity (NDO) or detrusor external sphincter dyssynergia. In literature we have data mainly on 300 U.I. of American BTX-A (Botox), but few data about English BTX-A (Dysport) with different dosages are reported without a clear profile of efficacy and safety. The only study published about the results of the repeat injections is based on the use of either toxin. We report our data about results and adverse effect using Dysport with different dosages after 1st injection and multiple reinjections excluding pts treated with Botox or either toxins.

MATERIAL & METHODS: From September 1999 to March 2003 we treated with intravesical BTX-A injection 178 pts. We selected a homogeneous group of 93 SCI pts with NDO treated with intravesical Dysport only. They were 63 males and 30 females (mean age 37.5 yrs). Spinal cord lesion level: 17 (18.2%) cervical, 65 (69.8%) dorsal, 11 (11.8%) lumbar. All pts have a NDO refractory to anticholinergic therapy and use intermittent catheterization (IC). We injected BTX-A in 20-30 sites into detrusor muscle. The dosages were 500, 750, 1000 U.I. Bladder diary was checked pre-treatment and during follow up. Urodynamic were performed before and after each treatment. Reinjections were planned at recurrence of urinary incontinence previous urodynamic assessment.

RESULTS: We recorded an average improvement of bladder capacity of 210 ml (range 180-420) at least for a period of 4 months. Urodynamic evaluation showed a significant decrease in mean maximum detrusor pressure from 60 to 20 cmH2O. A total of 165 treatments were performed: number of treatments, mean dosage, and mean duration time are reported in table. 5 pts (5.3%) referred hyposthenia with reduced supralesional muscle force. Hyposthenia disappeared from 2 to 4 weeks after injection and it depends on: high dosage BTX-A (1000 U.I.) used in SCI pts with cervical complete lesion.

CONCLUSIONS: Hyposthenia was no severe and had a temporary duration. For this reason we tried a lower dose and this series showed to be effective avoiding side effects. Clinical, urodynamic, and duration data show no significative differences between high and lower dosage. Reinjection data using Dysport did not reveal resistant to the toxin. Our study confirms the efficacy and tolerability of Dysport for the treatment of NDO after 1^st and repeated detrusor injection too.

664

MINIMALLY INVASIVE TECHNIQUE OF SACRAL NERVE STIMULATION THERAPY. PRELIMINARY RESULTS OF THE EUROPEAN REGISTRY

Spinelli M.¹, Del Popolo G.², Van Kerrebroek P.³, Ostardo E.⁴, Kiss G., H⁵eesakkers J.⁶, Varma J.⁷, Van den Hombergh U.⁸

¹Fornaroli Hospital, Department of Neuro-Urology, Magenta, Italy, ²Careggi Hospital, Department of Neuro-Urology, Firenze, Italy, ³University Hospital, Department of Urology, Maastricht, The Netherlands, ⁴Santa Maria degli Angeli Hospital, Department of Urology, Pordenone, Italy, ⁵University Hospital, Department of Neurology, Innsbruck, Austria, ⁶University Hospital, Department of Urology, Nijmegen, The Netherlands, ⁷Royal Victoria Infirmary, Department of Colorectal Surgery, New Castle, United Kingdom, ⁸Medtronic, Clinical Department, Tolochenaz, Switzerland

INTRODUCTION & OBJECTIVES: A new minimally invasive technique for sacral nerve stimulation (SNS) and tined lead electrode have been recently developed. This technique involves the percutaneous electrode placement under local anaesthesia with no incisions. Seven European centres experienced with SNS therapy decided to participate in a prospective registry to assess results of this technique on a large number of patients.

MATERIAL & METHODS: From January 2003, seven European centres started enrolling patients in the Tined Lead Registry if they were candidates for the SNS Therapy. Baseline evaluation included regular workup for the SNS. Tined Lead implant is performed under local anaesthesia and fluoroscopy. New designed electrode has 4 sets of tines and they allow proper electrode fixation and no additional suturing is needed. After the tined lead implant, patients were screened for up to 6 weeks and at this visit X ray was performed to confirm lead position. Diary was obtained to evaluate clinical improvement during the screening period. If there was more than 50% improvement patients underwent second stage, and the definitive neurostimulator placement. Followup was required at 6 months.

RESULTS: To date 67 patients are prospectively enrolled. Out of these 67 patients, 46 are females (69%). 87% of all patients underwent first stage implant while the other 7 patients had undergone PNE and a single stage implant. PNE was performed in 46 % of the patients before the first stage implant. Local anaesthesia was used in 83% of the cases. C-arm x-ray was always used. Screening (first stage or PNE) was considered successful in 76% of tested patients, and by now 41 of them were implanted with neurostimulator. In 13 patients screening was not successful and the lead was removed without complications. At baseline, 28 urge incontinent patients had 5.4±5.6 leaks a day, 4.2±3.1 pads per day and voiding frequency was 10±3.4. We observed reduction to 2.8±3.8 leaks a day, 2.2±4.6 pads/day and 7.4±2.4 voids per day. 31 Retention patients catheterized 3.7±1.75 times per day with 312.0±110.8 ml catheter volume/cath. At 6 months symptoms improved and cath volume/cath was 75.7±80.9 ml with 1.4±2.0 catheterizations per day and 5.6±1.6 voids a day. 6 months data were available for 9 UI and 16 retention patients.

CONCLUSIONS: Thanks to local anaesthesia and use of fluoroscopy screening validity has been greatly improved: the optimal electrode placement is achieved with relevant combination of motor and sensory responses and with visual control. This can be the reason for the high screening success rate when this technique is applied. Screening with the tined lead allows for longer therapy evaluation with no lead migration and if successful, there is no need to replace the testing lead but only to implant the neurostimulator. We expect that the clinical benefit of SNS therapy will improve by using this new technique, while more data are awaited.

665

INTRAVESICAL RESINIFERATOXIN VERSUS BOTULINUM-A TOXIN INJECTIONS FOR THE TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY

Giannantoni A.¹, Di Stasi S.², Stephen R.³, Navarra P.⁴, Pizzirusso G.¹, Mearini E.¹, Costantini E.¹, Porena M.¹

¹University of Perugia, Department of Urology, Perugia, Italy, ²Tor Vergata University, Department of Urology, Rome, Italy, ³Physion SRL, Department of Urology, Medolla (mo), Italy, ⁴Catholic University, Department of Pharmacology, Rome, Italy

INTRODUCTION & OBJECTIVES: Intravesical resiniferatoxin (RTX) and Botulinum-A toxin (BOTX) injections into the detrusor muscle have been introduced as treatments for neurogenic refractory detrusor overactivity. Actually, there are no clinical studies comparing intravesical RTX with Botulinum-A toxin injections. We investigated the effectiveness and safety of intravesical RTX and of BOTX, comparing their clinical and urodynamic effects over long term follow up in patients with neurogenic detrusor overactivity.

MATERIAL & METHODS: 25 spinal cord injured patients were randomly assigned to receive (a) intravesical administrations of RTX 0.6 microM in 50 ml of 0.9% NaCl over 45 min (n=13), or (b) injections of 300 units of BOTX diluted in 30 ml 0.9% NaCl into the detrusor muscle under cystoscopic control (n=12). RTX and BOTX treatments were repeated when there was recurrence of urinary symptoms and/or urodynamic worsening. Frequency of daily incontinence episodes, uninhibited detrusor contractions (UDC) threshold and maximum pressure, and maximum cystometric bladder capacity were measured at baseline and during follow up. Local and/or systemic side effects were noted.

RESULTS: RTX arm: mean follow up was 14.8±3 months; the number of instillations/patient was 8.6±1.9 and the mean time between two consecutive instillations was 51.6±8.2 days. BOTX arm: mean follow up was 14.2±3.9months; the number of treatments/ patient was 2.1±0.7 and the mean time between two consecutive injections was 6.8±1.5 months. Urodynamic results are showed in the Table. There was a significant increase in UDC threshold (p<0.02) and in maximum bladder capacity (p<0.01) in BOTX arm, as compared to RTX at 6, 12 and 18 mos follow up. We did not observe any local or systemic side effects in both arms.

CONCLUSIONS: Under the conditions imposed in this study, Botulinum-A toxin injection into the detrusor muscle is superior to intravesical RTX in terms of urodynamic results and clinical benefits in patients with neurogenic detrusor hyper-reflexia in a long term follow up. While the efferent parasympathetic innervation to the detrusor is adequately blocked by 300 units Botulinum-A toxin, the afferent nervous transmission is not completely controlled by the present dose of intravesical RTX.

667

BLADDER DYSFUNCTION IN AMBULATORY SPINAL CORD INJURY PATIENTS

Hamid R.¹, Bycroft J.¹, Shergill I.², Patki P.¹, Arya M.², Shah P.²

¹Royal National Orthopaedic Hospital, Department of Neuro-Urology, London, United Kingdom, ²Institute of Urology, Department of Urology, London, United Kingdom

INTRODUCTION & OBJECTIVES: To evaluate lower urinary tract dysfunction inpatients with incomplete spinal cord injuries who can walk.

MATERIAL & METHODS: In the out-patient clinic review we have identified 64 patients (M 43; F 21) with an incomplete spinal cord injury who are able to walk either independently or with the help of a stick. The mean age is 46 years (18-70 years). The group comprises of cervical (n=29), thoracic (n=9) and lumbar (n=26) spinal lesions. All patients underwent video-cystometrogram (VCMG) after recovery from spinal shock. The appropriate bladder management was instituted in the light of the VCMG result. All patients have been regularly followed up for a mean of 7 years (1 – 18 years) with either VCMG or flow rate and ultrasound scanning.

RESULTS: After recovery from spinal shock 40/64 patients (62.5%) could void spontaneously on urge confirmed on VCMG. Another 20/64 patients (31.2%) required clean self-intermittent catheterization (CSIC) and 4 (6%) had a suprapubic catheter inserted. On follow-up VCMG 19/40 (47.5%) patients voiding on urge were advised to perform CSIC due to hyper-reflexia, detrusor sphincter dyssynergia or incomplete bladder emptying. 5/20 (25%) patients performing CSIC were able to void on urge confirmed on VCMG. Overall 24/64 (37.5%) patients required a change in bladder management after reevaluation with VCMG. According to the level of injury, 22/29 (75.8%) patients from the cervical group initially voided on urge, however on follow-up VCMG 7/22 (31.7%) patients developed either detrusor hyper-reflexia or detrusor sphincter dyssynergia. 16/26 (62.3%) patients of the lumbar group were performing CSIC after initial VCMG. But 4/16 (25%) of these could void to completion without evidence of hyper-reflexia on follow-up VCMG.

CONCLUSIONS: To our knowledge there is one study in the literature evaluating the incidence of bladder dysfunction in neurologically intact patients with spinal injuries (Watanabe et al, 1998), but it is in the acute phase only. Our study is the first to reveal this sub-group of walking spinal cord injured patients who have neuropathic bladders. We have shown that although two third of these patients may initially be able to void spontaneously; the group require close follow-up with VCMG as half of them will develop detrusor hyper-reflexia at a later stage. Moreover the bladder function might improve over time and therefore it is important that they should have regular urological monitoring. Lastly it should be stressed upon these patients that even if they are walking and voiding normally they are likely to have neuropathic bladders unless proven otherwise by video-urodynamics.

669

CHRONIC PUDENDAL NERVE ELECTROSTIMULATION: A NEW MINIMALLY INVASIVE PROCEDURE FOR LEAD IMPLANT UNDER NEUROPHYSIOLOGICAL GUIDANCE

Spinelli M.¹, Malaguti S.², Giardiello G.³, Lazzeri M.⁴

¹Fornaroli Hospital, Department of Neuro-Urology, Magenta, Italy, ²Magenta Hospital, Department of Urology/Spinal Unit, Magenta, Italy, ³Medtronic Italia, S. S. Giovanni, Italy, ⁴S. Chiara Hospital, Department of Urology, Firenze, Italy

INTRODUCTION & OBJECTIVES: There have been several attempts to stimulate the pudendal nerve in order to achieve a beneficial effect on multiple impaired pelvic functions such as urinary and/or fecal incontinence, retention or constipation. We present here the methods and results of chronic pudendal nerve stimulation (CPNS).

MATERIAL & METHODS: Thirteen neurogenic patients (9 male, 4 female) underwent CPNS which is performed using neurophysiological monitoring to implant a lead into the Alcock’s canal close to the pudendal nerve. All patients went through complete neurophysiological and urodynamic evaluation at baseline and follow-up and were asked to fill out a bowel and voiding diary for 7 days. Main symptoms were: urge incontinence in 11 pts, urinary retention in 1 pt, severe constipation in 1 pt.

RESULTS: Five of the 11 pts with urge incontinence became continent during the screening phase and 2 pt improved by more 88% (from 9 to 1 daily incontinence episodes), 1 pt reduce by 50% the number of incontinence episodes and 3 patients had poor results. Four out of the 7 patients with constipation increased weekly evacuations from 2.5 to 7. One patient with associated fecal incontinence became continent. Urodynamic evaluation showed objective improvement in maximum cystometric capacity and in pressure at maximum cystometric capacity. All the six implanted patients displaying urge incontinence achieving continent at the last follow-up (average follow-up six months) although one of these was explanted one month after IPG implant because of erosion of the skin at the site of the connection between lead and extension cable.

CONCLUSIONS: Using a percutaneous technique originally developed for sacral neurostimulation CPNS is feasible and could widen the field of application of chronic electrical stimulation for treating urinary and fecal functional disorders in neurogenic patients. Further studies must carry out to identify the best selection criteria, the best stimulation parameters and to verify the long term results.

670

LONG-TERM RESULTS OF INTERSTIM THERAPY FOR VOIDING DISORDERS DEMONSTRATE SUSTAINED EFFICACY AND ACCEPTABLE SAFETY PROFILE

Van Kerrebroeck P.¹, Van Voskuilen A.¹, Lycklama A Nyeholt A.A.², Dijkema H.³, Bemelmans B.⁴, Fall M.⁵, Fowler C.⁶, Das A.⁷, Milam D.⁸, Siegel S.⁹, Van den Hombergh U.¹⁰, PAS Study Group

¹Academisch Ziekenhuis Maastricht, Department of Urology, Maastricht, The Netherlands, ²Academisch Ziekenhuis Leiden, Department of Urology, Leiden, The Netherlands, ³Twenteborg Ziekenhuis, Department of Urology, Almelo, The Netherlands, ⁴Academisch Ziekenhuis Radboud, Department of Urology, Nijmegen, The Netherlands, ⁵Sahlgrenska Hospital, University of Gothenburg, Department of Urology, Gothenborg, Sweden, ⁶The National Hospital for Neurology and Neurosurgery, Department of Urology, London, United Kingdom, ⁷Albany Medical College, Department of Urology, Albany, United States, ⁸Vanderbildt University, Department of Urology, Nashville, United States, ⁹Metropolitan Urologic Specialists, Department of Urology, St. Paul, United States, ¹⁰Medtronic Sarl, Europe, Tolchenaz, Switzerland

INTRODUCTION & OBJECTIVES: Sacral nerve stimulation therapy is a wellestablished treatment modality for various types of voiding dysfunction. Long-term data have been reported but mostly from single centre trials. This prospective, multicentre trial was designed to assess the long-term effectiveness and safety of the SNS therapy.

MATERIAL & METHODS: 16 centres in Europe, Canada and the US decided to participate in this long-term follow-up study as the continuation of the original randomized multicentre study that began prior to US market approval in 1997. A total of 156 patients (87% female, age 53 + 15) were enrolled in this follow-up study and all were implanted with the InterStim system (Medtronic, Minneapolis, USA). Voiding patterns were collected on diaries at 6 and 12 months, and annually until five years. Success was considered as: - 50% or more improvement in daily leaks reduction for urge incontinent (UI) patients (n=97) Either 50% or more improvement in daily voids or average voided volume or a decrease to a maximum of 7 daily voids for urgency-frequency (UF) patients (n=25) - 50% or more improvement in catheterized volume per catheterization for urinary retention (UR) patients (n=34). Patients who exited the study for the lack of efficacy or adverse event were considered therapy failure and were included in the analysis.

RESULTS: Five-year data were available from 110 patients, including 14 who exited for an adverse event (AE) or lack of efficacy and 16 with results carried forward from earlier visits. 46 Patients’ data were not available due to lost to follow-up, study withdrawal or data missing. 7 of those 46 patients were failures at their last follow-up.

Table 1: Changes in primary symptoms in the three subgroups of patients during Interstim therapy.
UI= Urinary Incontinence, UF= Urgency/Frequency and UR= Urinary Retention

Patients experienced 263 adverse events, of which 28 were device-related, 235 events were therapy-related, and 103 events required surgery. The most common adverse events were undesirable change in stimulation and pain. The most common events requiring surgery were pain at the lead or abdominal neurostimulator implant site.

CONCLUSIONS: InterStim therapy has a high success rate after one year that is maintained over five years for most of the patients. The incidence of adverse advents is reduced by the utilization of less invasive technologies and improvement in implant practices since patients were enrolled in this study.

671

BOTULINUM-A TOXIN AS AN ALTERNATIVE TREATMENT TO BLADDER AUGMENTATION IN CHILDREN WITH NEUROGENIC BLADDER DUE TO MYELOMENINGOCELE

Altaweel W., Corcos J., Robichaud C.

McGill University, Department of Urology, Montreal, Quebec, Canada

INTRODUCTION & OBJECTIVES: High intra-vesical pressure, decreased bladder capacity, and low detrusor compliance lead to incontinence and upper urinary tract damage in myelomeningocele patients. Clean intermittent catheterizations (CIC) and anticholinergic medications are the usual initial treatment of these conditions. Failure of this simple approach is classically treated by surgical bladder augmentation. We investigated prospectively the value of repeated injections of Botulinum-A toxin to avoid surgery in this group of patient.

MATERIAL & METHODS: We selected patients with neurogenic bladder secondary to myelomeningocele (who failed CIC and anticholinergic medications) on the basis of persistent incontinence and/or persistent high detrusor pressure and/or recurrent infections and/or upper tract deterioration. They were treated and followed in our centre from October 2000 to date. After base line history, physical examination and urodynamic study, we performed intra-detrusor injections of Botulinum-A toxin at the dose of 5 U/kg of body weight (up to a maximum of 300 U) in 20 to 40 sites. Clinical evaluation of possible complication was performed by telephone the day after the injection. Clinical and urodynamic evaluation was repeated approximately 3 months after each injection.

RESULTS: 20 myelomeningocele patients were included in our study. Their average age was 13 y.o (range 8-20). After intra-detrusor injections of Botulinum toxin A 13 patients improved. Their mean bladder capacity (MBC) increased from 197.7± 50.5cc to 285.3 ± 108.5cc (p<0.01), the maximum detrusor pressure (MDP) decreased from 44.7 ± 10 cm H2O to 29.9 ± 12.7 cm H2O (p<0.01) 10 patients had repeated injections: 6 patients had 2 injections, 3 had 3 injections and one had 4 injections .After the second injection (N= 10) the MBC increased from 181.2.8 ± 49.2cc to 331.2 ± 76.7cc (p<0.001), the MDP decreased from 45.3 ± 15 cm H2O to 29.6 ± 8.4 cm H2O (p<0.01). Repeat injections were required in all these 10 cases in an average of 8 months after the previous injection. 3 patients had one injection and failed to improve. They are scheduled to receive soon a second injection. 4 patients had 2 injections and failed to improve after the first and second injections. Two of them underwent already a successful bladder augmentation

CONCLUSIONS: Out of the 20 patients, 13 improved (65%) and 7 failed (35%). In other words we have been able to postpone invasive surgery in almost 2/3 of our patients using a minimally invasive technique. Intra-detrusor Botulinum-A toxin injections are an elegant, effective and safe therapeutic alternative to surgery in myelomeningocele patients who fail basic management with CIC and anticholinergic medication. Risk factors for success or failure, effect of repeated injections on the detrusor as well as ideal dose and injections site remain to be determined.

LB15

INTRAVESICAL HYALURONIC ACID FOR THE TREATMENT OF INTERSTITIAL CYSTITIS: AN UPDATE

Riedl C.¹, Daha L.², Hohlbrugger G.³, Pflueger H.²

¹Thermenklinikum Baden, Department of Urology, Baden, Austria, ²Hospital Lainz, Department of Urology, Vienna, Austria, ³University of Innsbruck, Department of Urology, Innsbruck, Austria

INTRODUCTION & OBJECTIVES: Current pathogenetic concepts of interstitial cystitis (IC) are based on an increased urothelial permeability due to dysfunction of the GAG (glycosaminoglycane)-layer and the urothelium. The efficacy of GAG-substitution therapy has been demonstrated with various drugs. Instillation of hyaluronic acid, a GAG-component, for IC therapy was introduced by Morales (J.Urol., 156: 45-48, 1996.) who found a 71% rate of symptom improvement. For the present study, we analyzed the outcome of intravesical hyaluronic acid therapy in IC patients treated at our institutions.

MATERIAL & METHODS: We retrospectively evaluated 95 IC patients by a questionnaire mailed several months after the last instillation. Patients had been assigned for hyaluronic acid therapy in case of increased potassium sensitivity demonstrated by the modified potassium sensitivity test (Daha et al., J.Urol., 170: 807, 2003). Weekly instillations of 50 cc hyaluronic acid 40 mg were performed until patients were free of symptoms or significantly improved to their satisfaction. Patients rated their pre- and posttreatment as well as their present symptoms on a visual analog scale (VAS, 0-10) and were asked to comment on their personal benefit on quality of life.

RESULTS: The average symptom score was 8.28 pretreatment, 3.51 posttreatment and 3.31 at the time of survey (mean follow-up time 7 months). Mean maximal bladder capacity with 0.9 % NaCl was 325cc (28-700) vs. 200cc (18-500) with 0.2M KCl (mean reduction 39%). 80/95 (84.2 %) of patients reported an improvement of ≥ 2 on the VAS after instillation therapy and 83/95 (87.3 %) at follow-up. The average improvement was 5.68 on VAS at the end of instillation therapy and 5.67 at the time of survey for patients responding to hyaluronic acid. An average of 11.4 instillations was performed to achieve this improvement rate. 31/95 patients (33%) needed an additional instillation course to maintain the therapeutic benefit. 78/95 patients(82%) confirmed that the present concept had improved their quality of life significantly and that they would undergo instillation therapy with hyaluronic acid again.

CONCLUSIONS: The present results confirm Morales¡äs preliminary report on the efficacy of intravesical hyaluronic acid therapy in IC and suggest that results are even better if patients are screened by the modified potassium sensitivity test. Potassium sensitive patients have a > 80% chance of significant symptom remission with hyaluronic acid instillations that is maintained over months.

LB17

SAFETY OF TOLTERODINE PR IN CHILDREN WITH DETRUSOR OVERACTIVITY: POOLED DATA FROM TWO LARGE PLACEBOCONTROLLED TRIALS

Nijman R.¹, Borgstein N.², Ellsworth P.³

¹Groningen University Hospital, Groningen, The Netherlands, ²Pfizer Ltd, Department of Clinical Development, Gi/gu, New London, United States, ³University of Massachusetts Medical Centre, Worcester, United States

INTRODUCTION & OBJECTIVES: Two placebo-controlled trials of similar design were conducted in children with urge incontinence suggestive of detrusor overactivity. Data from the 2 trials were combined to compare the safety profiles of tolterodine and placebo treatments.

MATERIAL & METHODS: Two randomized, double-blind, placebo-controlled, multicentre trials were conducted to evaluate the efficacy and safety of prolonged release (PR) tolterodine in 5- to 10-year-old children with urge urinary incontinence suggestive of detrusor overactivity. After a 1-week run-in, patients were randomized in a 2:1 ratio to receive tolterodine PR 2 mg or placebo once daily for 12 weeks. Assessments occurred at the end of the run-in period and at weeks 4, 8, and 12. A total of 271 patients (57% males, 43% females) continued from 1 of the studies into an open-label extension study.

RESULTS: 710 patients participated in these 2 studies; 486 received tolterodine and 224 placebo. The treatment groups were well balanced with respect to demographic and baseline characteristics. Similar proportions of patients discontinued the studies (8% tolterodine, 11% placebo) and in each group 3% of patients discontinued due to adverse events. The most common event leading to discontinuation was difficulty in micturition (either symptomatic or defined as postvoid residual urine volume ≥20% of theoretical bladder capacity): 5 tolterodine patients and 1 placebo patient. No occurrences of urinary retention were reported. Three adverse events frequently associated with anticholinergic treatment occurred at low rates: diarrhea (3.3 % tolterodine vs. 0.8 % placebo); constipation (2.1 % vs. 0.8 %); and abnormal behaviour (1.6 % vs. 0.4 %). In addition, 2 common childhood ailments occurred more frequently in the tolterodine PR group compared with the placebo group: rhinitis (1.6 % vs. 0.4 %) and ear infection (1.0 % vs. 0.4 %). Dry mouth, nausea, and fatigue occurred slightly less frequently in the patients taking tolterodine. Serious adverse events occurred in 1% of patients in each group. More than 80% remained in the extension study for 6 months or more, and slightly over 50% completed the 12-month study. The most frequent reasons for discontinuation were lack of efficacy (17%) and improvement in baseline symptoms (12%). Difficulty with micturition occurred in 1.8 %, and there were no episodes of urinary retention.

CONCLUSIONS: Tolterodine PR was well tolerated in children 5 to 10 years of age. The incidence of adverse events associated with anticholinergic treatment was generally low. Some adverse events (eg, constipation) occurred slightly more frequently in tolterodine patients than placebo patients yet remained low; others (eg, dry mouth) occurred less frequently with tolterodine PR. Prolonged treatment was not associated with any new or unexpected adverse events.

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