Mesh Repair of Anterior Vaginal Wall Prolapse

This study has been completed.
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00420225
First received: January 9, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Tampere

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00420225     History of Changes
Other Study ID Numbers: Tampere University Hospital
Study First Received: January 9, 2007
Last Updated: January 9, 2007
Health Authority: Finland: TEO

Keywords provided by University of Tampere:
Cystocele
surgery
mesh
genital prolapse

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on September 18, 2014