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NCT00622076 Clinical Trial

Postoperative Catheterization After Anterior Colporrhaphy

Cystocele Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00622076
Other study ID # 05-P-47
Secondary ID
Status Unknown status
Phase N/A
First received February 13, 2008
Last updated February 13, 2008
Start date January 2006
Est. completion date December 2009

Study information
Verified date January 2008
Source Atrium Medical Center
Contact Mirjam Weemhoff, Drs
Phone +31433876747
Email mwee@sgyn.azm.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 230
Est. completion date December 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• postoperative catheterization
postoperative catheterization after anterior colporrhaphy for five days versus two days.

Locations
Country Name City State
Netherlands atriumMC Heerlen
Netherlands Maastricht university medical center Maastricht

Sponsors (2)
Lead Sponsor Collaborator
Atrium Medical Center Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6-8 hours after removal of catheter
Secondary how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy 6 weeks after surgery
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