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
• 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

• Catheter Complications
• Pain

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