Status:
COMPLETED
Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Pain
Catheter Complications
Eligibility:
MALE
18+ years
Phase:
NA
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 l...
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 regard...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate,
- Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
- Be willing/able to adhere to follow up visits
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01465594
Start Date
November 1 2011
End Date
April 1 2015
Last Update
May 20 2015
Active Locations (1)
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1
University Hospital, Urological department
Düsseldorf, Germany, 40225