A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse - Full Text View

Sponsored by:	Roskilde County Hospital
Information provided by:	Roskilde County Hospital
ClinicalTrials.gov Identifier:	NCT00442247

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

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Keywords provided by Roskilde County Hospital:

anterior vaginal wall prolapse, Pelvicol, biomesh
Anterior vaginal wall prolapse

Study placed in the following topic categories:

Genital Diseases, Female
Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Uterine Prolapse

Uterine Diseases
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009