Postoperative Catheterization After Anterior Colporrhaphy

Not Applicable

• Conditions: Cystocele; Cystitis
• Interventions: Procedure: postoperative catheterization

• Registration Number: NCT00622076
• Lead Sponsor: Atrium Medical Center

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 Description

Not available

Study Timeline

• Study Start: 2006-01
• Status Verified: 2008-01
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Last Update Submitted: 2008-02-13
• Study First Posted: 2008-02-22
• Last Update Posted: 2008-02-22
• Primary Completion: 2009-06
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	postoperative catheterization	postoperative catheterization after anterior colporrhaphy during five days.
2.	postoperative catheterization	postoperative catheterization after anterior colporrhaphy during two days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Maastricht university medical center; 🇳🇱 Maastricht, Netherlands

atriumMC; 🇳🇱 Heerlen, Netherlands