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

Not Applicable

Completed

• Conditions: Pain; Catheter Complications
• Interventions: Procedure: transurethral catheter after EERPE/ RALP; Procedure: suprapubic catheter after EERPE /RALP

• Registration Number: NCT01465594
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

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

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

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transurethral catheter after EERPE/ RALP	transurethral catheter after EERPE/ RALP	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
suprapubic catheter after EERPE /RALP	suprapubic catheter after EERPE /RALP	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
suprapubic catheter after EERPE /RALP	transurethral catheter after EERPE/ RALP	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
transurethral catheter after EERPE/ RALP	suprapubic catheter after EERPE /RALP	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

Primary Outcome Measures

Name	Time	Method
Superiority of suprapubic catheter after EERPE	2nd postoperative day	Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort

Secondary Outcome Measures

Name	Time	Method
Comparison of QoL in both arms measured by visual analogue (pain) scale	1st and 3rd until 5th postoperative day	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.

Trial Locations

Locations (1)

University Hospital, Urological department; 🇩🇪 Düsseldorf, Germany