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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02108431

Enrollment

160

Registered

2014-04-09

Start date

2013-02-28

Completion date

2013-11-30

Last updated

2014-04-09

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

Conditions

Prostate Cancer

Keywords

urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain

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.

Interventions

DEVICEballoon catheter for suprapubic bladder-drainage

suprapubic tube removal was allowed when the anastomosis was watertight, Day 5

DEVICEballoon catheter for transurethral bladder-drainage

transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results

None listed

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