Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

Detailed Description
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It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.

Official Title
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Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

Conditions
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Prolapse

Intervention / Treatment
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* Procedure: anterior vaginal repair (colporrhaphy)
* Procedure: abdominal paravaginal defect repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial. Exclusion Criteria: Patients with at least 2 previous prolapse surgeries Patients who are pregnant or planning to have a pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior colporrhaphy<br>Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) | Procedure: anterior vaginal repair (colporrhaphy)<br>* vaginal repair<br>Procedure: abdominal paravaginal defect repair<br>* abdominal repair<br>|
| Active Comparator: Paravaginal defect repair<br>Abdominal paravaginal defect repair cystocele (dropped bladder) | Procedure: anterior vaginal repair (colporrhaphy)<br>* vaginal repair<br>Procedure: abdominal paravaginal defect repair<br>* abdominal repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery | POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystocele, prolapse, anterior repair, colporrhaphy