Mesh Repair of Anterior Vaginal Wall Prolapse

Anterior Vaginal Wall Prolapse Clinical Trial

Official title:

Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420225
• Other study ID #: Tampere University Hospital
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: January 9, 2007
• Start date: April 2003
• Est. completion date: May 2008

Study information

• Verified date: January 2007
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: TEO
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Vaginal Wall Prolapse
• Prolapse
• Uterine Prolapse

Intervention

Device:
• Low-weight prolypropylene mesh

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Department of Obstetrics and Gynaecology	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of anterior vaginal wall prolapse
Secondary	Postvoidal residual urine
Secondary	Symptom resolution
Secondary	Complications