Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy

May 19, 2015 updated by: Heinrich-Heine University, Duesseldorf

Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy

The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Study Type

Interventional

Enrollment (Actual)

106

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
      • Düsseldorf, Germany, 40225
        • University Hospital, Urological department

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:

  • Adenocarcinoma of the prostate,
  • Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
  • Be willing/able to adhere to follow up visits

Exclusion Criteria:

  • Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
  • Contraindications for anticholinergic drugs
  • Waist measurement > 100 cm
  • No written informed consent
  • Age < 18 years
  • Subjects with known narrow-angle glaucoma

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transurethral catheter after EERPE/ RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
Procedure: transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP
suprapubic catheter after EERPE /RALP
Active Comparator: suprapubic catheter after EERPE /RALP
Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics
Procedure: transurethral catheter after EERPE/ RALP
transurethral catheter after EERPE/ RALP
Procedure: suprapubic catheter after EERPE /RALP
suprapubic catheter after EERPE /RALP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority of suprapubic catheter after EERPE
Time Frame: 2nd postoperative day
Superiority of suprapubic catheter versus transurethral catheter regarding QoL /Patient comfort
2nd postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of QoL in both arms measured by visual analogue (pain) scale
Time Frame: 1st and 3rd until 5th postoperative day
Comparison of QoL in both arms measured by visual analogue (pain) scale, EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics.
1st and 3rd until 5th postoperative day

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Christian Arsov, Dr, Heinrich Heine Universitat

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

November 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • catheterstudy001

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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