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

Study Overview
=================
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.

Official Title
-----------------
Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: balloon catheter for suprapubic bladder-drainage
* Device: balloon catheter for transurethral bladder-drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age of 18 Years Voluntarily agreement to participate in this study Written informed-consent Release of medical records for regulatory or research purposes Clinically organ-confined prostate cancer Exclusion Criteria: BMI >40 History of catheterization History of radiation History of chemotherapy Person's participating in any other research Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balloon catheter for transurethral bladder-drainage<br>intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy | Device: balloon catheter for transurethral bladder-drainage<br>* transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5<br>* Other names: UROMED;|
| Active Comparator: balloon catheter for suprapubic bladder-drainage<br>intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy | Device: balloon catheter for suprapubic bladder-drainage<br>* suprapubic tube removal was allowed when the anastomosis was watertight, Day 5<br>* Other names: suprapubic device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days | 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) | postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bacteriuria | Second void urine sample after catheter removal | 5th day after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain