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

• Sponsor: Zealand University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00442247
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Prolapse	Device: Pelvicol	N/A

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.

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Sep 1, 2004
• Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. Difference in POP-Q measurements for vaginal prolapse []

Secondary Outcome Measures

1. Affect on bladder function after surgery for anterior vaginal wall prolapse []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00442247
• Other Study ID Numbers: Feb-UH-2007
• First Posted: Mar 1, 2007
• Last Update Posted: Mar 1, 2007
• Last Verified: Feb 1, 2007

• Keywords provided by , ,: anterior vaginal wall prolapse, Pelvicol, biomesh; Anterior vaginal wall prolapse
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse

Study Results

No Results Posted as of Mar 1, 2007