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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-08-31

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.

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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.

Conditions

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Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anterior colporrhaphy

Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)

Group Type ACTIVE_COMPARATOR

anterior vaginal repair (colporrhaphy)

Intervention Type PROCEDURE

vaginal repair

abdominal paravaginal defect repair

Intervention Type PROCEDURE

abdominal repair

Paravaginal defect repair

Abdominal paravaginal defect repair cystocele (dropped bladder)

Group Type ACTIVE_COMPARATOR

anterior vaginal repair (colporrhaphy)

Intervention Type PROCEDURE

vaginal repair

abdominal paravaginal defect repair

Intervention Type PROCEDURE

abdominal repair

Interventions

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anterior vaginal repair (colporrhaphy)

vaginal repair

Intervention Type PROCEDURE

abdominal paravaginal defect repair

abdominal repair

Intervention Type PROCEDURE

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.