Mesh Repair of Anterior Vaginal Wall Prolapse

Phase 3

Completed

• Conditions: Anterior Vaginal Wall Prolapse

• Registration Number: NCT00420225
• Lead Sponsor: Tampere University

Brief Summary

The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.

Detailed Description

Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias.

Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study

Study Timeline

• Study Start: 2003-04
• Status Verified: 2007-01
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Last Update Submitted: 2007-01-09
• Study First Posted: 2007-01-11
• Last Update Posted: 2007-01-11
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 202

Inclusion Criteria

• Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

Read More

Exclusion Criteria

• an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence of anterior vaginal wall prolapse

Secondary Outcome Measures

Name	Time	Method
Postvoidal residual urine
Symptom resolution
Complications

Trial Locations

Locations (1)

Tampere University Hospital, Department of Obstetrics and Gynaecology; 🇫🇮 Tampere, Finland