Back to resultsA Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Primary Purpose
Vaginal Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pelvicol
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Prolapse focused on measuring anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse
Eligibility Criteria
Inclusion Criteria:
- Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology
Exclusion Criteria:
- Recurrent vaginal prolapse, wault prolapse
Sites / Locations
- Dept. of Obstetrics and Gynecology
Outcomes
Primary Outcome Measures
Difference in POP-Q measurements for vaginal prolapse
Secondary Outcome Measures
Affect on bladder function after surgery for anterior vaginal wall prolapse
Full Information
NCT ID
NCT00442247
First Posted
February 28, 2007
Last Updated
February 28, 2007
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00442247
Brief Title
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Official Title
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zealand University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.
Detailed Description
Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Prolapse
Keywords
anterior vaginal wall prolapse, Pelvicol, biomesh, Anterior vaginal wall prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Pelvicol
Primary Outcome Measure Information:
Title
Difference in POP-Q measurements for vaginal prolapse
Secondary Outcome Measure Information:
Title
Affect on bladder function after surgery for anterior vaginal wall prolapse
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology
Exclusion Criteria:
Recurrent vaginal prolapse, wault prolapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Hviid, MD
Organizational Affiliation
Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Obstetrics and Gynecology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
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