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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Zealand University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00442247
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zealand University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Further study details as provided by Zealand University 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442247


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

ClinicalTrials.gov Identifier: NCT00442247     History of Changes
Other Study ID Numbers: Feb-UH-2007
First Submitted: February 28, 2007
First Posted: March 1, 2007
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by Zealand University 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