Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy

Study Overview
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Brief Summary
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The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

Detailed Description
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Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Official Title
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Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy

Conditions
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Pain, Catheter Complications

Intervention / Treatment
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* Procedure: transurethral catheter after EERPE/ RALP
* Procedure: suprapubic catheter after EERPE /RALP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adenocarcinoma of the prostate, Subjects treated by conventional or robotic assisted laparoscopic prostatectomy Be willing/able to adhere to follow up visits Exclusion Criteria: Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer Contraindications for anticholinergic drugs Waist measurement > 100 cm No written informed consent Age < 18 years Subjects with known narrow-angle glaucoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: transurethral catheter after EERPE/ RALP<br>Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics | Procedure: transurethral catheter after EERPE/ RALP<br>* transurethral catheter after EERPE/ RALP<br>Procedure: suprapubic catheter after EERPE /RALP<br>* suprapubic catheter after EERPE /RALP<br>|
| Active Comparator: suprapubic catheter after EERPE /RALP<br>Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics | Procedure: transurethral catheter after EERPE/ RALP<br>* transurethral catheter after EERPE/ RALP<br>Procedure: suprapubic catheter after EERPE /RALP<br>* suprapubic catheter after EERPE /RALP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority of suprapubic catheter after EERPE | Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort | 2nd postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of QoL in both arms measured by visual analogue (pain) scale | Comparison of QoL in both arms measured by visual analogue (pain) scale, EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics. | 1st and 3rd until 5th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Measurement