Postoperative Catheterization After Anterior Colporrhaphy

February 13, 2008 updated by: Atrium Medical Center

Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele

Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

230

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 Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Heerlen, Netherlands, 6401 CX
        • Recruiting
        • atriumMC
        • Contact:
          • Martine Wassen, Drs
          • Phone Number: +31454766666
        • Contact:
          • Paul Kampschöer, Drs
          • Phone Number: +31455766666
        • Sub-Investigator:
          • Martine Wassen, Drs
      • Maastricht, Netherlands, 6229 HC
        • Recruiting
        • Maastricht University Medical Center
        • Contact:
          • Mirjam Weemhoff, Drs
        • Principal Investigator:
          • Mirjam Weemhoff, Drs

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all patients planned for a cystocele repair

Exclusion Criteria:

  • patients who already have voiding problems before the operation not related to the cystocele
  • patients that are not capable of understanding our patient information form because of mental status or language

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
Active Comparator: 1
postoperative catheterization after anterior colporrhaphy during five days.
Procedure: postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Other Names:
  • catheterization protocol
Active Comparator: 2.
postoperative catheterization after anterior colporrhaphy during two days
Procedure: postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.
Other Names:
  • catheterization protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy
Time Frame: 6-8 hours after removal of catheter
6-8 hours after removal of catheter

Secondary Outcome Measures

Outcome Measure
Time Frame
how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy
Time Frame: 6 weeks after surgery
6 weeks after surgery

Collaborators and Investigators

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

Sponsor

Atrium Medical Center

Collaborators

Maastricht University

Investigators

  • Study Director: Frans Roumen, Dr, Atrium Medical Center
  • Principal Investigator: Mirjam Weemhoff, DRS, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2006

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2008

Last Update Submitted That Met QC Criteria

February 13, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-P-47

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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