Mesh Repair of Anterior Vaginal Wall Prolapse - Full Text View

Sponsored by:	University of Tampere
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00420225

Purpose

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.

Condition	Intervention	Phase
Anterior Vaginal Wall Prolapse	Device: Low-weight prolypropylene mesh	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study

Further study details as provided by University of Tampere:

Primary Outcome Measures:

Recurrence of anterior vaginal wall prolapse

Secondary Outcome Measures:

Postvoidal residual urine
Symptom resolution
Complications

Estimated Enrollment:	202
Study Start Date:	April 2003
Estimated Study Completion Date:	May 2008

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420225

Locations

Finland
Tampere University Hospital, Department of Obstetrics and Gynaecology
Tampere, Finland, 33521

Sponsors and Collaborators

University of Tampere

Investigators

Principal Investigator:

Kari Nieminen

Tampere University Hospital, Department of Obstetrics and Gynecology

More Information

Study ID Numbers:	Tampere University Hospital
Study First Received:	January 9, 2007
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00420225
Health Authority:	Finland: TEO

Keywords provided by University of Tampere:

Cystocele
surgery
mesh
genital prolapse

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Body Weight
Cystocele
Urinary Bladder Diseases
Prolapse

ClinicalTrials.gov processed this record on January 14, 2009