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Mesh Repair of Anterior Vaginal Wall Prolapse

Primary Purpose

Anterior Vaginal Wall Prolapse

Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Low-weight prolypropylene mesh
Sponsored by
Tampere University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Vaginal Wall Prolapse focused on measuring Cystocele, surgery, mesh, genital prolapse

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Tampere University Hospital, Department of Obstetrics and Gynaecology

Outcomes

Primary Outcome Measures

Recurrence of anterior vaginal wall prolapse

Secondary Outcome Measures

Postvoidal residual urine
Symptom resolution
Complications

Full Information

First Posted
January 9, 2007
Last Updated
January 9, 2007
Sponsor
Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00420225
Brief Title
Mesh Repair of Anterior Vaginal Wall Prolapse
Official Title
Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tampere University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Vaginal Wall Prolapse
Keywords
Cystocele, surgery, mesh, genital prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Low-weight prolypropylene mesh
Primary Outcome Measure Information:
Title
Recurrence of anterior vaginal wall prolapse
Secondary Outcome Measure Information:
Title
Postvoidal residual urine
Title
Symptom resolution
Title
Complications

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Nieminen
Organizational Affiliation
Tampere University Hospital, Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital, Department of Obstetrics and Gynaecology
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18716704
Citation
Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, Heinonen PK. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1611-6. doi: 10.1007/s00192-008-0707-7. Epub 2008 Aug 21.
Results Reference
derived

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Mesh Repair of Anterior Vaginal Wall Prolapse

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