A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Roskilde County Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00442247
First received: February 28, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Vaginal Prolapse
Device: Pelvicol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Further study details as provided by Roskilde County Hospital:

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

Estimated Enrollment: 60
Study Start Date: September 2004
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00442247

Locations
Denmark
Dept. of Obstetrics and Gynecology
Roskilde, Denmark, 4000
Sponsors and Collaborators
Roskilde County Hospital
Investigators
Principal Investigator: Ulla Hviid, MD Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00442247     History of Changes
Other Study ID Numbers: Feb-UH-2007
Study First Received: February 28, 2007
Last Updated: February 28, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Roskilde County Hospital:
anterior vaginal wall prolapse, Pelvicol, biomesh
Anterior vaginal wall 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 July 26, 2014