Clinical Trial: Postoperative Catheterization After Anterior Colporrhaphy

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Atrium Medical Center

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Atrium Medical Center

Dates:
Date Received: February 13, 2008
Date Started: January 2006
Date Completion: December 2009
Last Updated: February 13, 2008
Last Verified: January 2008