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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
balloon catheter for suprapubic bladder-drainage
balloon catheter for transurethral bladder-drainage
Sponsored by
St. Antonius Hospital Gronau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

balloon catheter for transurethral bladder-drainage

balloon catheter for suprapubic bladder-drainage

Arm Description

intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy

intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of patients with bacteriuria
Second void urine sample after catheter removal

Full Information

First Posted
March 31, 2014
Last Updated
April 6, 2014
Sponsor
St. Antonius Hospital Gronau
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1. Study Identification

Unique Protocol Identification Number
NCT02108431
Brief Title
Prospective Randomized Trial Comparing Urinary Diversion After Robot-assisted Radical Prostatectomy
Official Title
Superior Postoperative Patient Comfort in Suprapubic Drainage Versus Transurethral Catheterization Following Robot-assisted Radical Prostatectomy: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital Gronau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
urinary diversion, urethral catheter, suprapubic tube, radical prostatectomy, robotic surgery, discomfort, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
balloon catheter for transurethral bladder-drainage
Arm Type
Experimental
Arm Description
intraoperatively placement of transurethral catheter after robot-assisted radical prostatectomy
Arm Title
balloon catheter for suprapubic bladder-drainage
Arm Type
Active Comparator
Arm Description
intraoperatively placement of suprapubic catheter after robot-assisted radical prostatectomy
Intervention Type
Device
Intervention Name(s)
balloon catheter for suprapubic bladder-drainage
Other Intervention Name(s)
UROMED, suprapubic tube, suprapubic device
Intervention Description
suprapubic tube removal was allowed when the anastomosis was watertight, Day 5
Intervention Type
Device
Intervention Name(s)
balloon catheter for transurethral bladder-drainage
Other Intervention Name(s)
UROMED
Intervention Description
transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5
Primary Outcome Measure Information:
Title
Change of postoperative pain related to urinary drainage objectified by numeric rating scale (NRS) questionnaire within 5 days
Description
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)
Time Frame
postoperatively on day 1, 2, 3, 4 and 5 in the morning, at noon and in the evening
Secondary Outcome Measure Information:
Title
Number of patients with bacteriuria
Description
Second void urine sample after catheter removal
Time Frame
5th day after the surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jawid Habibzada, MD.
Organizational Affiliation
St. Antonius Hospital Gronau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael Godes, MD.
Organizational Affiliation
St. Antonius Hospital Gronau
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Urology, Pediatric Urology and Urologic Oncology; St. Antonius-Hospital Gronau GmbH
City
Gronau
ZIP/Postal Code
48599
Country
Germany

12. IPD Sharing Statement

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

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