Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: balloon catheter for transurethral bladder-drainage; Device: balloon catheter for suprapubic bladder-drainage

• Registration Number: NCT02108431
• Lead Sponsor: St. Antonius Hospital Gronau

Brief Summary

The purpose of the study is to determine, whether the urinary diversion via suprapubic cystostomy compared to transurethral catheterization after robot-assisted radical prostatectomy superior the postoperative patient comfort and reduce the postoperative bacteriuria.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Study First Submitted: 2014-03-31
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-06
• Last Update Submitted: 2014-04-06
• Study First Posted: 2014-04-09
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

1. Minimum age of 18 Years
2. Voluntarily agreement to participate in this study
3. Written informed-consent
4. Release of medical records for regulatory or research purposes
5. Clinically organ-confined prostate cancer

Exclusion Criteria

1. BMI >40
2. History of catheterization
3. History of radiation
4. History of chemotherapy
5. Person's participating in any other research
6. Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balloon catheter for transurethral bladder-drainage	balloon catheter for transurethral bladder-drainage	intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy
balloon catheter for suprapubic bladder-drainage	balloon catheter for suprapubic bladder-drainage	intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy

Primary Outcome Measures

Name	Time	Method
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days	postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening	To analyse the development of the postoperative pain related to urinary drainage patients completed NRS questionnaire three times a day: in the morning, at noon and in the evening until discharge of the catheter (regular 5 days after the surgery)

Secondary Outcome Measures

Name	Time	Method
Number of patients with bacteriuria	5th day after the surgery	Second void urine sample after catheter removal

Trial Locations

Locations (1)

Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH; 🇩🇪 Gronau, Germany