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NCT01465594 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01465594
Other study ID # catheterstudy001
Secondary ID
Status Completed
Phase N/A
First received November 2, 2011
Last updated May 19, 2015
Start date November 2011
Est. completion date April 2015

Study information
Verified date May 2015
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Procedure:
• transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
• suprapubic catheter after EERPE /RALP
suprapubic catheter after EERPE /RALP

Locations
Country Name City State
Germany University Hospital, Urological department Düsseldorf

Sponsors (1)
Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Superiority of suprapubic catheter after EERPE Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort 2nd postoperative day Yes
Secondary 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 Yes
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