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

Not Applicable

Completed

• Conditions: Prolapse
• Interventions: Procedure: anterior vaginal repair (colporrhaphy); Procedure: abdominal paravaginal defect repair

• Registration Number: NCT00271102
• Lead Sponsor: Geisinger Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-12-29
• Study First Submitted QC: 2005-12-29
• Study First Posted: 2005-12-30
• Study Start: 2006-01
• Primary Completion: 2010-02
• Study Completion: 2011-08
• Results First Submitted: 2011-08-17
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Results First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

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Exclusion Criteria

• Patients with at least 2 previous prolapse surgeries
• Patients who are pregnant or planning to have a pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior colporrhaphy	abdominal paravaginal defect repair	Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
Anterior colporrhaphy	anterior vaginal repair (colporrhaphy)	Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
Paravaginal defect repair	anterior vaginal repair (colporrhaphy)	Abdominal paravaginal defect repair cystocele (dropped bladder)
Paravaginal defect repair	abdominal paravaginal defect repair	Abdominal paravaginal defect repair cystocele (dropped bladder)

Primary Outcome Measures

Name	Time	Method
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery	4 years	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States