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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465594

Enrollment

106

Registered

2011-11-07

Start date

2011-11-30

Completion date

2015-04-30

Last updated

2015-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Complications, Pain

Keywords

Pain Measurement

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

Interventions

PROCEDUREtransurethral catheter after EERPE/ RALP

transurethral catheter after EERPE/ RALP

PROCEDUREsuprapubic catheter after EERPE /RALP

suprapubic catheter after EERPE /RALP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026