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.

191

INITIAL 100 PATIENTS TREATED BY LAPAROSCOPIC PROMONTO-FIXATION FOR PROLAPSE

F. Rozet ¹, H. Widmer ¹, F. Dugardin ¹, F. Combes ¹, H. Baumert ¹, X. Cathelineau ¹, J. Adorno Rosa ¹, B. Guilloneau 1, G. Vallancien ¹

¹ Institut Mutualiste Montsouris, Department of Urology, Paris, France

INTRODUCTION & OBJECTIVES: Prolapse is a benign condition that can have a significant impact on women’s quality of life. Open colposacropexy is an already approved corrective surgery that has shown good long term anatomical and functional results. We hereby describe the series of our initial 100 patients treated with laparoscopic promontofixation.

MATERIAL & METHODS: Five surgeons performed a total of 100 promontofixations in a four year period. The procedure consists of installation of an anterior mesh in the inter-vesico/vaginal plane, fixed to the vagina, and when needed a second mesh between the rectum and the vagina, fixed on the levator ani muscles. The two meshes are then sutured on the sacral promontory. A TVT is afterwards performed when stress incontinence is present. Follow-up was conducted with a home self assessment questionnaire.

RESULTS: 100 anterior meshes, 41 posterior were installed. 51 TVT’s and 10 Burch procedures were performed. Mean follow-up was 2.5 years, operating time was 148 and 159 minutes for anterior and anterior and posterior mesh installation respectively, blood loss 68 +/- 231cc and hospital stay was 3.7 +/- 1.3 days. 67 patients answered the questionnaire: 82% of these patients were satisfied. Recurrence rate was 6%. Major complications consisted of 2 vaginal erosions by the mesh, 1 intestinal occlusion (incarceration of ileum in the Douglas pouch) necessitating bowel resection and 2 urinary retentions requiring TVT section.

CONCLUSIONS: Laparoscopic promontofixation is a feasible procedure that offers good short term results. It offers the advantages of minimally invasive surgery for a benign condition. Longer follow-up is needed to validate long term results.

196

COMPARING DRY DAYS IN WOMEN WITH DIFFERENT STRESS URINARY INCONTINENCE SEVERITY LEVELS TREATED WITH DULOXETINE AND PLACEBO

R. Bump ¹, C. Hooper ², G. Peng ³, I. Yalcin ³

¹ Lilly Research Laboratories, Medical Advisor, Indianapolis, United States, ² Lilly Research Laboratories, Global Scientific Information and Communications, Indianapolis, United States, ³ Lilly Research Laboratories, Statistics, Indianapolis, United States

INTRODUCTION & OBJECTIVES: Four controlled duloxetine trials for women with stress urinary incontinence (SUI) were analysed by 2 incontinence severity strata (<14 and ≥ 14 incontinence episodes/wk). Lesser improvements in incontinence episode frequency (IEF) and Incontinence Quality of Life (I-QOL) scores were demonstrated with duloxetine in the less severe stratum. However, both strata had nearly identical rates of improvement with treatment (65% and 64%) on a validated improvement scale. Our aim was to investigate why the less severe stratum was equally satisfied with treatment even though IEF and I-QOL results suggested less improvement.

MATERIAL & METHODS: We identified the number of days subjects were free of incontinence (dry days) at baseline and endpoint and compared treatments by severity strata. The database included 1913 women aged 22-84 years identified with a validated SUI clinical algorithm. They were randomised to receive duloxetine or placebo through a 12-week double-blind trial. Subjects recorded incontinence episodes on diaries for 7 days before each visit.

RESULTS: The table shows the distribution of dry days at baseline and endpoint. Overall, a larger proportion of the duloxetine than placebo subjects were dry ≥ 4 days/wk in both strata (more severe p<.001; less severe p=.09). At endpoint, duloxetine subjects in the less severe stratum were more likely to be dry most days compared with those in the more severe stratum (p<.001). When the upper 50% of responders were considered, more duloxetine than placebo subjects were dry most days (more severe: duloxetine 49.4%, placebo 29.5%, p<.001; less severe: duloxetine 90.9%, placebo 79.4%, p<.003).

CONCLUSIONS: Less severely incontinent women were equally satisfied with duloxetine treatment even though IEF and I-QOL changes suggested they improved less than more severely incontinent women because those in the less severe group were more likely to have the elimination of most or all of their incontinence.

197

CONTROLLED TRIAL OF DULOXETINE ALONE, PELVIC FLOOR MUSCLE TRAINING ALONE, COMBINED TREATMENT, AND NO TREATMENT IN WOMEN WITH STRESS URINARY INCONTINENCE (SUI)

J. Schagen van Leeuwen 1, D. Elser 2, R. Freeman 3, G. Ghoniem 4, Y. Zhao 5, I. Yalcin 5, R. Bump 6

(1) St. Antonius Hospital, Department of Obstetrics and Gynaecology, Nieuwegein, The Netherlands, (2) Christ Medical Centre, Department of Uro-Gynaecology, Oak Lawn, United States, (3) Scotswood, Department of Gynaecology, Plymouth, United Kingdom, (4) Cleveland Clinic Florida, Section of Female Urology, Voiding Dysfunction, Weston, United States, (5) Lilly Research Laboratories, Department of Statistics, Indianapolis, United States, (6) Lilly Research Laboratories, Medical Department, Indianapolis, United States

INTRODUCTION & OBJECTIVES: Pelvic floor muscle training (PFMT) is an accepted treatment for SUI. There is no widely approved pharmacological option, but duloxetine has been shown to be superior to placebo for women with this condition. Our aim was to compare the effectiveness of 4 treatment options that included duloxetine and PFMT for women with moderate to severe SUI.

MATERIAL & METHODS: 201 women with symptoms of SUI between the ages of 18-75 years were enrolled. Women had to have ≥ 2 SUI episodes/day AND EITHER a urodynamic diagnosis of pure stress incontinence within 6 months of enrolment OR a positive cough stress test, normal voiding frequencies, and the absence of symptoms of enuresis and urge incontinence. Women were randomly assigned to 12 weeks of blinded treatment that included duloxetine, placebo, PFMT, and imitation PFMT (IPFMT). The 4 treatment groups were duloxetine alone (duloxetine + IPFMT, n=52), PFMT alone (placebo + PFMT, n=50), combined treatment (duloxetine + PFMT, n=52), and no treatment (placebo + IPFMT, n=47). Three PFMT and IPFMT sessions included feedback from a continence care specialist. The primary efficacy variable was the percent change from baseline to endpoint in incontinence episode frequency (IEF). Secondary efficacy measures were the change in the Incontinence Quality of Life (I-QOL) questionnaire total score and the percent change in pad use. Analyses included an a priori pooled diary analysis using the intent-to-treat (ITT) population and a post hoc last visit analysis using the completers’ population.

RESULTS: The table lists results for both analyses. The ITT population IEF analysis demonstrated the superiority of duloxetine, with or without PFMT, compared with either no treatment or with PFMT alone. However, both pad and condition-specific quality of life analyses suggest greater improvement with combined treatment than single treatment. The completers population analysis also demonstrated efficacy of duloxetine with or without PFMT. There was evidence that combined treatment was more effective than either treatment alone.

^ap<.05 vs. no treatment; ^bp<.05 vs PFMT; no other differences were significant but power was limited by small sample sizes, especially in the completers analysis

CONCLUSIONS: In some analyses, duloxetine was superior to PFMT; however there was evidence for additional efficacy with combined duloxetine and PFMT. This additive effect may be due to complementary effects and complementary modes of action of duloxetine and PFMT.

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.

788

ASSESSING THE QUALITY OF LIFE IMPACT AND CLINICAL RELEVANCE OF IMPROVEMENTS IN STRESS INCONTINENCE

Yalcin I., Bump R.

Lilly Research Laboratories, Medical Department, Indianapolis, United States

INTRODUCTION & OBJECTIVES: The clinical relevance of "cured" versus "improved" stress urinary incontinence (SUI) has been debated in the surgical, behavioural, and pharmacological literature for decades. In an effort to assess the relative impact of cure and improvement on patients, we compared decreases in incontinence episode frequency (IEF) and number of days with no incontinence episodes (dry days) with change and ending scores respectively from a validated patient-completed incontinence-specific quality of life instrument.

MATERIAL & METHODS: 1913 women with SUI in Africa, Australia, Europe, and North and South America, were enrolled in 4 randomized, controlled 12-week trials comparing duloxetine 80 mg/day and placebo. Subjects completed seven-day urinary diaries before each visit and a validated condition-specific quality of life questionnaire (IQOL) at each visit. The percent change in IEF from baseline to endpoint and the number of dry days per week at endpoint were computed from the diaries. The clinical impact of improved SUI was assessed by comparing the percent decrease in IEF with changes in IQOL scores (Table 1). The impact of cure was assessed by comparing the number of dry days with I-QOL scores at endpoint (Table 2).

RESULTS: Inflection points for increases in I-QOL were observed at the 50% and 80% IEF reduction levels (Table 1). The 4.2 point difference between the 40% and the 50% IEF reduction level exceeds the minimum clinically important difference established for I-QOL. There was a steady increase in I-QOL scores with an increasing number of dry days per week (Table 2). I-QOL scores were highest when subjects were dry every day and similarly high when subjects were dry most days of the week (4 or more).

CONCLUSIONS: The data suggest that women with SUI attach clinical relevance both to reduced incontinence and to increased dryness. Substantial improvement in conditionspecific quality-of-life is perceived when incontinence is reduced by 50% or more. Even a single day increase in number of dry days has a noticeable impact on patient’s quality of life with some plateauing of effect when the majority of days in the week are devoid of accidents.

790

THE CHANGE OF OVERACTIVE BLADDER SYMPTOMS AFTER TENSIONFREE VAGINAL TAPE

Lee K.S., Choe J.H., Cho J.

Sungkyunkwan University School of Medicine, Department of Urology, Seoul, Korea, South

INTRODUCTION & OBJECTIVES: Overactive bladder (OAB) symptoms especially urinary urgency and urge incontinence remain difficult to treat as independent entities and as co-factors in patients with stress urinary incontinence (SUI). The data for the efficacy and prognosis of the tension-free vaginal tape (TVT) in these patients is not enough. We assessed the change of the OAB symptoms after TVT in female SUI patients combined by OAB.

MATERIAL & METHODS: 254 women who received a TVT for SUI confirmed by history, physical examination and urodynamic study (UDS) were identified from database during 2002 to 2003. Patients underwent TVT surgery by a single surgeon. Patients with neuropathic bladder, urethral diverticulum, urinary tract infection, neoplasm were excluded. Of all 68 patients (27%) had OAB. Finally, 41 women (mean age 55 years) who were followed for over 3 months postoperatively, were evaluated. A total of 29 patients (71%) had urge incontinence and 15 (37%) in these patients had detrusor overactivity (DO) on UDS. There were no differences in clinical characteristics between patients with DO and those without DO. The protocol used for pre- and postoperative evaluation included 3-day frequency/volume chart, urological questionnaire for OAB and QoL evaluation. A criterion for cure of SUI was no leakage at stress test and for OAB symptoms was resolution of OAB symptoms.

RESULTS: The overall cure rate was 95% (39/41) in SUI, 42% (17/41) in OAB symptoms and 45% (13/29) in urge incontinence at mean follow-up duration of 8.5 months. The mean number of voids in 24 hours were decreased by 27% (from 11.9 ± 3.8 to 8.7 ± 2.7, p<0.001). There was no significant change in the mean of functional bladder capacity in before and after surgery. Patients without DO showed a higher cure rate than those with DO in OAB symptoms (46% vs. 33%, p=0.04) and urge incontinence (50% vs. 39%, p=0.03) respectively. Quality of life after treatment was rated as ‘most satisfied’ by 11 patient (27%), ‘satisfied’ by 16 (39%), ‘fair’ by 9 (22%), ‘dissatisfied’ by 4 (10%) and ‘worst’ by 1 (2%). Patients with DO showed low satisfaction rate significantly. There were no signs of defective healing, rejection or significant complications.

CONCLUSIONS: TVT surgery can be used in stress urinary incontinence with OAB symptoms including urge incontinence. The operation can preferably be performed if the patient has no DO urodynamically because women with DO correlated with lesser cure rate of OAB symptoms and lower satisfaction. In patients with DO, a proper counsel is recommended preoperatively.

791

VALIDATION OF AN INCONTINENCE TREATMENT PATIENT SATISFACTION QUESTIONNAIRE

Yalcin I., Peng G., Koke S., Hooper C., Bump R.

Lilly Research Laboratories, Medical Department, Indianapolis, United States

INTRODUCTION & OBJECTIVES: Assess the construct validity of a 4-item, selfadministered, Patient Satisfaction Questionnaire (PSQ-4) using data from clinical studies of women with stress urinary incontinence (SUI) treated with duloxetine.

MATERIAL & METHODS: 1635 women in Europe, North and South America, Australia, and Africa with SUI of at least 3 months duration were enrolled in 3 large double-blind phase 3 trials of duloxetine versus placebo. Each trial had an open-label extension. The PSQ-4 items rated the patient’s impression of control of the problem, her satisfaction with drug treatment, and her willingness to continue the drug and to recommend the drug to another (each on a 7-point Likert scale). A validated questionnaire rating treatment outcome (Patient Global Impression of Improvement, PGII) and a validated condition-specific quality of life questionnaire (I-QOL) were administered along with the new questionnaire. In addition, incontinence episode frequency (IEF) was calculated from diaries. Construct validity of each PSQ-4 question was assessed by correlating its endpoint to percent change in IEF, change in I-QOL and endpoint PGI-I (Spearman’s correlations). The treatment differences were analyzed by the Cochran-Mantel-Haenszel statistic.

RESULTS: Each PSQ-4 question was significantly correlated with the other outcome measures (see table; all p<.0001). There were significant treatment differences in the distribution of responses favouring duloxetine for 3 of the 4 questions ("control of the problem", "satisfaction with drug treatment", and "recommend drug to another"), confirming the overall favourable impressions of the drug. Overall, 61%, 58%, 63% and 71% of duloxetine subjects had a favourable response to the PSQ-4 questions. This is consistent with the observation that 65% of the duloxetine-treated subjects rated their condition as better on the PGI-I instrument. There was not a significant treatment difference in the distribution of responses for the "willing to continue present drug" question. However, most subjects in both treatment groups said they would want to continue treatment, all were aware of the open-label extensions, and over 90% of subjects did enter these extensions.

CONCLUSIONS: The construct validity of the PSQ-4 has been established. The PSQ-4 treatment results support the findings of other efficacy analyses for duloxetine in women with stress urinary incontinence.

792

HOW BOTHERSOME IS URINARY INCONTINENCE? RESULTS FROM A STUDY OF WOMEN IN FOUR EUROPEAN COUNTRIES

Voss S.¹, Lose G.², Papanicolaou S.³, Sykes D.³, Hunskaar S.⁴

¹Lilly Research Centre, European Product Team, Windlesham, United Kingdom, ²Glostrup University Hospital, Department of Obstetrics and Gynaecology, Copenhagen, Denmark, ³Lilly Research Centre, Erl Wood Health Outcomes, Windlesham, United Kingdom, ⁴Lilly Research Centre, University of Bergen, Bergen, Norway

INTRODUCTION & OBJECTIVES: There is little information about how bothersome women find urinary incontinence; to assess this we surveyed a large number of women in 4 European countries.

MATERIAL & METHODS: Initially we conducted a mailed survey of 29,500 households’ representative of the general population in four European countries (10,000 in Spain and 6,500 each in France, Germany and the UK). The overall response rate was 58%. A 13-item questionnaire assessed the prevalence of UI symptoms during the preceding 30 days and previous treatment for UI. Each questionnaire was to be completed by adult (aged 18 and over) female household members. A more detailed follow-up questionnaire was mailed to a sample of responders who had experienced UI in the previous 30 days. The degree of bothersomeness of their UI from this follow-up survey is reported here. Women were asked about the type of UI symptoms that they experienced, what sort of doctor they first discussed their leakage with, how they perceived their doctor would describe the severity of their symptoms (mild, moderate or severe) and how bothersome their leakage was to them (not at all, slightly, moderately, very and extremely bothersome).

RESULTS: 2,960 questionnaires were sent. The overall response rate was 53%. Only 31% of responding women had discussed their UI with a physician, this ranged from 24% in Spain, UK 25%, France 33% and Germany 40%. The type of doctor women first discussed UI with varied between countries, in the UK (n=179) General Practitioners (GPs, 86%) were the first consulted most often, in France (n=173) GPs (46%) or obstetrician gynaecologists (OBGYN’s, 49%), in Germany (n=184) mainly OBGYN’s (60%) and in Spain (n=135) mostly GPs (56%) but also OBGYN’s (37%). 70% of women who had reported discussing their UI with a physician thought that their doctor perceived their condition as mild, 26% as moderate but only 4% severe. Conversely, nearly half (46%) of the responding women found their leakage to be moderately to extremely bothersome and one fifth (19%) very or extremely bothersome, the highest being for women with mixed UI symptoms (23% very or extremely bothersome). The reasons that women found their UI most bothersome (very or extremely) related to times when their condition may have revealed itself (due to odour, when they were out of the house, when it became obvious to others, when there was a need to change underwear or clothing and when travelling in a car or public transport); the main reasons were similar in all four countries.

CONCLUSIONS: Preliminary analysis of these data show that although women may be very bothered by their leakage symptoms, most thought that their physician would consider the problem to be mild. Potential bias in responders to the follow-up questionnaire will be explored in future. Women should be educated about treatment options and encouraged to consult their physician.

793

DOES LEARNING OF CLEAN INTERMITTENT CATHETERIZATION (CIC) BEFORE PUBOVAGINAL SLING SURGERY AFFECT PATIENT'S CHOICE FOR OPERATION AND POST-OPERATIVE PERCEPTION OF CIC?

Cobussen- Boekhorst J.g.l., Heesakkers J.p.f.a., Debruyne F.m.j., Bemelmans B.l.h.

University Medical Center, St. Radboud, Urology, Nijmegen, The Netherlands

INTRODUCTION & OBJECTIVES: Urinary retention may occur after a pubovaginal sling procedure for stress urinary incontinence. Therefore, women diagnosed with stress urinary incontinence who were offered a sling procedure, were taught cic by a specialized nurse. We examined if pre-operative learning of cic affects the patients choice for operation and the perception of cic after the operation.

MATERIAL & METHODS: Patients were trained in performing cic during a one-hour session at the outpatient clinic. The patient had to perform cic once daily at home at least four times during one day, preferably also outdoors. Cic performance and occurrence of technical or emotional problems was checked. Patients were scheduled for surgery if no problems were encountered. If a patient had problems with cic the urologist discussed other treatment options. Inclusion criteria: age > 18 years, able to perform cic and eligible for a sling-procedure. The patients received a postal questionnaire. Emotional aspects were assessed using VAS scores.

RESULTS: 34 women were included. In all cases cic was taught pre-operatively. 27 Women underwent a sling procedure, of which 13 had to perform cic . Seven women were excluded for a sling procedure, because cic was problematical. In one case because of technical reasons, once because of medical problems and in 5 cases there were emotional problems with cic . 28 of the 34 women could be analysed. Of these, 25 underwent a sling procedure. In the other cases, once medical problems appeared and in two cases the patients cancelled the operation after consulting the urologist. Of the 25 operated women, 13 women had to perform cic postoperatively, the duration ranging from 1 month to continuously. Cic frequency ranged from 1 to 6 times daily. All 13 patients judged the teaching of cic positively (VAS-score: 7,3-9,5), the necessity to learn cic pre-operatively was answered 8 times positively (VAS-score: 6,7-9,7) and 4 times negatively (VAS-score: 0,8-3,0). Eight of 12 patients answered questions about present perception of performing cic. One patient was unsatisfied (VAS-score 3,7), one judged indifferently (VAS-score 5,4) and 6 answered positively (VAS-score 5,9-10,0)

CONCLUSIONS: The risk of retention and the teaching of cic are important to discuss with patients before a sling operation is performed. Patients who are at risk for retention or post void residual urine after a sling-procedure should always have the option to learn cic before operation in order to make a decision between operation and the risk for cic or to reject the operation. In this study we found that perception of cic is good when being taught beforehand.

LB5

TRANSMITTERS CONTRIBUTING TO THE VOIDING CONTRACTION IN FEMALE RATS

Streng T.¹, Talo A.², Andersson K.E.¹

¹Lund University Hospital, Department of Clinical and Experimental Pharmacology, Lund, Sweden, ²Division of Genetics And Physiology, Laboratory of Animal Physiology, Turku, Finland

INTRODUCTION & OBJECTIVES: It is well established that there are both cholinergic (acetylcholine) and purinergic (ATP) components in rat bladder contraction, and that both contribute to bladder emptying. However, there are possibly other transmitters that contribute to bladder emptying. Typically, the micturition cycle in the rat can be divided into four phases, as recorded by transvesical cystometry. However, it has still not been established how the transmitters contribute to the different phases, including the intraluminal pressure high frequency oscillations (IPHFOs). In this study, we used α,β-methylene-ATP (desensitizing purinoceptors) and atropine (blocking muscarinic receptors) to study in detail the contribution of acetylcholine and ATP to the different phases of the voiding contraction, rhabdosphincter electromyography (RB EMG), and to urine flow.

MATERIAL & METHODS: Adult anesthetized (chloral hydrate, 0.9 g/kg ip) female Sprague-Dawley rats, weighing 225-270 g, were used in the study. A 20 gauge iv infusion cannula was inserted through the bladder apex into the lumen for saline (0.9 % NaCl) infusion (0.185 ml/min) and intravesicalpressure recordings. An ultrasonic flow probe connected to a flowmeter was used for measurement of the urine flow from the distal urethra. An iv cannula was introduced into the femoral vein. After baseline recordings, atropine (1 mg/kg), α,β-methylene-ATP (0.5 mg/kg), or both, were injected iv. Both drugs were dissolved in saline. Three representative voidings were chosen for analysis before and after a drug administration.

RESULTS: α,β-Methylene-ATP decreased significantly (n=8; p<0.05) the maximal bladder pressure during the first phase, whereas atropine was less effective. The maximal bladder pressure during the second phase was also reduced. The IPHFOs were seen after both treatments. Atropine reduced significantly (n=9; p<0.01) the maximal bladder pressure during the third phase. Combination of α,β-methylene-ATP and atropine abolished the micturition contraction. The amplitude of RB EMG was not changed after treatments. The maximal urine flow rate was reduced by both α,β-methylene-ATP (n=8; p<0.001) and atropine (n=9; p<0.05). After administration of both α,β-methylene-ATP and atropine, urine flow stopped and overflow incontinence developed.

CONCLUSIONS: ATP contributes mainly to the initial and acetylcholine to the later phases of the voiding cycle in the rat. Neither α,β-methylene-ATP, nor atropine abolished the IPHFOs. Even after blockade of the receptors for one of the transmitters and in the presence of IPHFOs, the bladder can still empty; if both receptors are blocked, overflow incontinence develops, suggesting that even if further transmitters are taking part in the voiding contraction, their physiological significance is questionable.

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