348

SAFETY AND EFFICACY OF PHYTOTHERAPY IN THE TREATMENT OF CHRONIC PROSTATITIS/ CHRONIC PELVIC PAIN SYNDROME: RESULTS OF THE PROSPECTIVE PLACEBO-CONTROLLED MULTICENTRE AUSTRIAN TRIAL

Reissigl A.¹, Pointner J.¹, Marberger M.², Brunner J.¹, Obwexer S.¹, Djavan B.²

¹Hospital of Bregenz, Department of Urology, Bregenz, Austria, ²University of Vienna, Department of Urology, Vienna, Austria

INTRODUCTION & OBJECTIVES: To evaluate the efficacy and safety endpoints in patients with chronic prostatitis/chronic pelvic pain syndrome (category III A/B CP/CPPS) treated with Serenoa repens.

MATERIAL & METHODS: Men with Category IIIA/B CPPS were prospectively enrolled in 2 institutions and randomized to Permixon and matched with a placebocontrol group. Both groups were comparable in terms of age, prostate volume and prostate-specific antigen (PSA). The response to therapy was evaluated at 6 and 12 weeks, 6 mo, 12mo and 18 mo after treatment based on efficacy parameters including Patients Subjective Global Assessment (SGA), the total NIH Chronic Prostatitis Symptom Index (CPSI), the pain, voiding and quality of life/impact domains of the CPSI, safety data, PSA and prostate volume.

RESULTS: 142 patients were enrolled (72 Permixon; 70 control group). By 12 and 18mo, 76.4% and 71.8%, in the active group (serenoa repens) had at least mild improvement (35-50% improvement) of the SGA and NIH-CPSI versus, 24.3 and 18.5 % in the control group. Furthermore, 55.7% and 52.6% reported moderate or marked improvement (50% or greater improvement) versus 18.8% and 14.7%, respectively, of patients in the control group. At 18 mo, 68.4%, 56.6% and 54.7% of patients in the active group demonstrated a 50% or greater improvement in IPSS, Q_max and QOL score, respectively, compared with 15.2%, 9.1% and 11.6%, respectively, in the control group. Overall, a 30% reduction of the NIH-CPSI score was observed in the active group versus 6.3% in the control group. Prostate volume did not change significantly in both groups. However, PSA decreased by 18% in the active group at 18 mo. whereas, PSA did not differ from Baseline in the control group.

CONCLUSIONS: This multi-centre study suggests that Permixon may provide clinical benefit in patients with Category IIIA/B CPPS. A moderate/marked improvement of the SGA and NIH-CPSI is observed in over 60% of patients. The decrease in serum PSA in CP/CPPS patients treated with Serenoa repens (not observed in men with BPH) suggests a different action pathway.

799

CHRONIC PELVIC FLOOR ELECTROSTIMULATION FOR TREATMENT OF REFRACTORY INTERSTITIAL CYSTITIS

Nissenkorn I.¹, Radziszewski P.², Dobronski P.², Borkowski A.², De Jong P.³

¹Tel Aviv University, Sackler School of Medicine, Tel Aviv, Israel, ²University of Warsaw School of Medicine, Department of Urology, Warsaw, Poland, ³Groote Schuur Hospital, Department of Obstetrics and Gynecology, Cape Town, South Africa

INTRODUCTION & OBJECTIVES: Electrostimulation has been used extensively and successfully for the treatment of urinary dysfunction. In this study we present the effect of pelvic floor electrostimulation using the BioControl miniaturo^TM-I system as a novel treatment option for refractory Interstitial Cystitis (IC). IC is a chronic syndrome characterized by a constellation of lower urinary tract irritative symptoms and pain. Clinically, IC is diagnosed on the basis of its major symptoms, i.e., urinary frequency, urgency and/or pelvic pain in the absence of any identifiable cause, such as bacterial infection or tumor. The etiology of IC is unknown, but may involve microbiologic, immunologic, mucosal, neurogenic, or other as yet unidentified factors.

MATERIAL & METHODS: Ten female patients, mean age 54 years old (range: 39-72 years), were recruited for the miniaturo^TM-I for Interstitial Cystitis study in two centers and completed a mean follow up period of 10 months (range: 3 to 18 months). Patients underwent a simple surgical procedure (under epidural or local anesthesia). Stimulation treatment was performed using a bipolar stimulation electrode placed adjacent to the midurethra and connected to a pacemaker-like electrostimulator located subcutaneously in the anterior abdominal wall. Efficacy was measured by comparing the results of the pre- and post-treatment voiding and pain diary and quality of life questionnaires.

RESULTS: Eight out of the 10 patients demonstrated sustained improvement in all three measured parameters, urinary frequency, pain and quality of life, at the last postoperative visit. At 10 months, the patients’ frequency of micturition was considerably decreased, per voiding diaries, from an average 32.4±20.6 per day down to 14.7±10.0 (p=0.01). In parallel, their pain (on a visual analogue scale of 1 to 10) was significantly decreased from 4.6±1.7 down to 1.0±1.6 (p=0.001). Concomitantly, a significant decrease was observed in the O’Leary-Sant Symptoms and Problem Index scores (from 31.6±3.4 down to 15.4±13.5 (p=0.001)). Five post implant surgical procedures were performed to resolve adverse events. Eight of the patients were satisfied with the results of the surgery and continue the treatment. Two patients who were not satisfied withdrew their consent to participate in the study and subsequently had their system removed 6 and 9 months after implantation.

CONCLUSIONS: In that cohort of patients, this form of electrostimulation therapy has been demonstrated to be effective and well tolerated for the treatment of refractory IC. Longer follow-up period is required to establish the efficacy of this method.

807

THE USE OF ALFUZOSIN FOR THE TREATMENT OF CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME (CP/CPPS): IS THERE A ROLE FOR A-BLOCKERS?

Argyropoulos A., Papadopoulos G., Liapis D., Polyzois K., Liakatas I., Fragoulis A., Lykourinas M.

Athens General Hospital 'G.Gennimatas', Department of Urology, Athens, Greece

INTRODUCTION & OBJECTIVES: Chronic pelvic pain syndrome (CPPS), as described in the last NIH Consensus in 1995, is a condition affecting many male patients. So far, various treatment options have been proposed, and many physicians have prescribed at some time an a-blocker to their patients, though adequate data supporting their use are lacking in the literature. The aim of our study was to investigate the efficacy of Alfuzosin compared to standard treatment in CP/ CPPS.

MATERIAL & METHODS: 100 patients who were examined as outpatients in our clinic during the last year and diagnosed as suffering from CP / CPPS were randomised to receive either Alfuzosin 5 mg bid, or other —antibiotic-treatment for a period of 3 months. The Greek version of the NIH-Chronic Prostatitis Symptom Index was used to evaluate the baseline score and the response to treatment.

RESULTS: 65 male patients were finally included in the analysis (30 on Alfuzosin and 35 on standard treatment). Mean age was 51,3 years. At the end of the 3 months of therapy with Alfuzosin, a significant decrease in NIH-CPSI total and pain score was noted (8,6 vs. 4,4 decrease, p=0,01). Patients with higher symptom scores before treatment were those who benefited the most. After 3 months from discontinuation of treatment, the symptom score deteriorated in both groups, but this was more profound on patients who received Alfuzosin. Mild adverse effects were seen in the Alfuzosin group.

CONCLUSIONS: Our results indicate that 3 months of Alfuzosin is a safe and welltolerated therapy for patients with CP/ CPPS that produces a significant decrease in symptom scores, compared to standard treatment. Nevertheless, 3 months after the end of therapy, NIH-CPSI score deteriorated in both groups, suggesting that a more prolonged duration of therapy may be more effective.

808

TRANSURETHRAL NEEDLE ABLATION FOR CHRONIC NON BACTERIAL PROSTATITIS: A 3-YEAR FOLLOW-UP STUDY

Giannakopoulos X.¹, Entezari K.², Schulman C.², Sofikitis N.¹, Zlotta A.²

¹University Hospital of Ioannina, , Ioannina, Greece, ²Univ. Clinics of Brussels-Erasme Hospital, Urology, Brussels, Belgium

INTRODUCTION & OBJECTIVES: Chronic non bacterial prostatitis (III-A) is an entity disappointing both for physicians and patients. Recently transurethral needle ablation of the prostate (TUNA) has been evaluated for the treatment of chronic non bacterial prostatitis in small series and very short follow-up. We report here our long term data (3 year follow-up) of TUNA used for the treatment of chronic non bacterial prostatitis.

MATERIAL & METHODS: 39 consecutive patients (mean age 37, range 32-46) who failed conventional therapy with a clinical diagnosis of prostatitis type III-A and symptoms lasting for at least 36 months were treated by TUNA. Peak flow rate, a specific symptom score on prostatitis symptoms and quality of life questionnaires were analysed before and after therapy. Semen quality, motility and morphology, expressed prostatic secretion leucocytosis (EPS, > 15 WBC before TUNA) as well as the VB3 test (>15 WBC in the urine specimen before TUNA) were compared to baseline data at 1, 3, 6, 12, 24 and 36 months after TUNA using the student t-test.

RESULTS: 2 patients were lost for follow-up. Quality of life (4.7 to 2.0) and symptom score (16.2 to 5.1) significantly improved from baseline at 36 months follow-up (all p<0,001). 31/37 patients had an improvement in the specific prostatitis symptom score > 50%. EPS (83.4 to 21.9/fields) and VB3 (24.3 to 8.2/fields) significantly improved at 36 months follow-up as compared to pre-treatment values (both p<0.001). No change was observed in morphology, number of spermatozoïds and motility of the sperm when comparing pre and post TUNA data. Side effects included transient (1week) perineal discomfort. Acute urinary retention occurred in 12 patients (31%) but resolved spontaneously in all cases within 1 week.

CONCLUSIONS: This study with a 3 year follow-up period supports the place of TUNA as a possible and effective treatment option for patients with chronic non-bacterial prostatitis who have failed conventional therapies. Randomised studies using TUNA for the treatment of this entity should be encouraged.

816

CHRONIC PROSTATITIS - A NATIONWIDE SURVEY OF ALL UROLOGISTS IN SWITZERLAND

Zbrun S., Schumacher M., Studer U.E., Hochreiter W.

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

INTRODUCTION & OBJECTIVES: To document the current perception and management of Chronic Prostatitis (CP) by urologists in Switzerland.

MATERIAL & METHODS: In May 2003, we sent a questionnaire to all 154 urologists practicing in Switzerland at that time. The questionnaire consisted of 19 questions concerning prevalence, aetiology, diagnostic assessment, treatment and prognosis of CP. The returned questionnaires were statistically analyzed.

RESULTS: Of the 154 questionnaires sent, 76 were returned (49%). Respondents see a median of 10 CP patients per month, 3 of them being newly diagnosed cases. This would correspond to a prevalence of 255 and an incidence of 76 per 100’000 inhabitants for CP in Switzerland. Twenty-one percent of respondents believe in an infectious aetiology of CP, whereas 28% think that infection is not the aetiology of CP. For routine diagnostic assessment, the most commonly used tests are digital rectal examination, dipstick urine analysis, ultrasound for post-void residual urine assessment and microscopic urine analysis (91%, 75%, 73% and 67% of respondents, respectively). Microscopic and microbiologic analysis of post prostate massage urine (VB3) as well as symptom assessment by the National Institute of Health—Chronic Prostatitis Symptom Index NIHCPSI are less frequently used (46%, 34% and 12% of respondents, respectively). The predominant treatment prescribed for CP is antibiotics (75%). Ninety-three percent of respondents who regard infection as aetiology of CP routinely use antibiotics as first line therapy. Surprisingly, also 80% of respondents who do not believe in an infectious aetiology prescribe antibiotics. When asked about the therapeutic consequences of VB— analysis, almost half of respondents would prescribe antibiotic treatment in the absence of leukocyturia. Treatments with non-steroidal anti-inflammatory drugs or alpha-blockers are less frequently adopted as first line therapy (30% and 17% of respondents, respectively). The mean overall success rates of initial therapy reported (all treatments included) is 60%, but the mean recurrence rate after 6 months reported is 48%.

CONCLUSIONS: One of 5 urologists believes in an infectious aetiology of CP. However, 3 of 4 urologists prescribe antibiotic treatment as first line therapy. Only a minority of respondents routinely perform prostate massage with analysis of VB3 when suspecting CP, and antibiotic treatment is often prescribed even without evidence of inflammation in VB3. To our knowledge, this is the first European study of this kind.

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.

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