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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108431
• Other study ID #: U1111-1155-1458
• Status: Completed
• Phase: N/A
• First received: March 31, 2014
• Last updated: April 6, 2014
• Start date: February 2013
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: St. Antonius Hospital Gronau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• balloon catheter for suprapubic bladder-drainage
suprapubic tube removal was allowed when the anastomosis was watertight, Day 5
• balloon catheter for transurethral bladder-drainage
transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5

Locations

Country	Name	City	State
Germany	Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH	Gronau

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital Gronau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of patients with bacteriuria	Second void urine sample after catheter removal	5th day after the surgery	Yes