Postoperative Catheterization After Anterior Colporrhaphy

Sponsor

Atrium Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00622076

Collaborator

Maastricht University (Other)

230

Enrollment

Locations

Arms

Duration (Months)

115

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele Cystitis	Procedure: postoperative catheterization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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