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Mesh Repair of Anterior Vaginal Wall Prolapse

T

Tampere University

Status and phase

Completed
Phase 3

Conditions

Anterior Vaginal Wall Prolapse

Treatments

Device: Low-weight prolypropylene mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT00420225
Tampere University Hospital

Details and patient eligibility

About

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.

Full 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

Sex

Female

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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