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

April 6, 2014 updated by: J.H. Witt, St. Antonius Hospital Gronau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gronau, Germany, 48599
        • Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: balloon catheter for transurethral bladder-drainage
intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy
Device: balloon catheter for transurethral bladder-drainage
transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5
Other Names:
  • UROMED
Active Comparator: balloon catheter for suprapubic bladder-drainage
intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy
Device: balloon catheter for suprapubic bladder-drainage
suprapubic tube removal was allowed when the anastomosis was watertight, Day 5
Other Names:
  • UROMED
  • suprapubic tube
  • 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
Time Frame: 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)
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
Time Frame: 5th day after the surgery
Second void urine sample after catheter removal
5th day after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital Gronau

Investigators

  • Study Chair: Jawid Habibzada, MD., St. Antonius Hospital Gronau
  • Study Chair: Michael Godes, MD., St. Antonius Hospital Gronau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 6, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 6, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1155-1458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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