Postoperative Catheterization After Anterior Colporrhaphy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystocele, Cystitis

Intervention / Treatment
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* Procedure: postoperative catheterization


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>postoperative catheterization after anterior colporrhaphy during five days. | Procedure: postoperative catheterization<br>* postoperative catheterization after anterior colporrhaphy for five days versus two days.<br>* Other names: catheterization protocol;|
| Active Comparator: 2.<br>postoperative catheterization after anterior colporrhaphy during two days | Procedure: postoperative catheterization<br>* postoperative catheterization after anterior colporrhaphy for five days versus two days.<br>* Other names: catheterization protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, Catheterization, colporrhaphy, cystocele, cystitis