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

Heinrich-Heine University, Duesseldorf

Status: Completed

Conditions: Catheter Complications; Pain

Treatments: Procedure: transurethral catheter after EERPE/ RALP; Procedure: suprapubic catheter after EERPE /RALP

Study type: Interventional

Funder types: Other

Identifiers

NCT01465594

catheterstudy001

Details and patient eligibility

About

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.

Full 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

Enrollment: 106 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

transurethral catheter after EERPE/ RALP

Active Comparator group

Description:

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

Treatment:

Procedure: suprapubic catheter after EERPE /RALP

Procedure: transurethral catheter after EERPE/ RALP

suprapubic catheter after EERPE /RALP

Active Comparator group

Description:

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

Treatment:

Procedure: suprapubic catheter after EERPE /RALP

Procedure: transurethral catheter after EERPE/ RALP