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

St. Antonius Hospital Gronau

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: balloon catheter for suprapubic bladder-drainage; Device: balloon catheter for transurethral bladder-drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02108431

U1111-1155-1458

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

balloon catheter for transurethral bladder-drainage

Experimental group

Description:

intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy

Treatment:

Device: balloon catheter for transurethral bladder-drainage

balloon catheter for suprapubic bladder-drainage

Active Comparator group

Description:

intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy

Treatment:

Device: balloon catheter for suprapubic bladder-drainage