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Clinical Trials/NCT00622076
NCT00622076
Unknown
Not Applicable

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

Atrium Medical Center2 sites in 1 country230 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystocele
Sponsor
Atrium Medical Center
Enrollment
230
Locations
2
Primary Endpoint
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
Last Updated
18 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
December 2009
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Study Sites (2)

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