Randomized Controlled Trial Comparing Acellular Collagen Biomesh (Pelvisoft) to Polypropylene Mesh(Pelvitex) for Sacral Colpopexy

Not Applicable

Completed

• Conditions: Uterine Prolapse

• Registration Number: NCT00564083
• Lead Sponsor: Atlantic Health System

Brief Summary

This research protocol is a randomized controlled trial. It is being done to compare and find out the relative differences between the materials, (Pelivisoft) "natural organic mesh" to poly propylene mesh (Pelvitex) "manmade mesh" after a surgery known as sacral colpopexy. This surgery involves supporting the prolapsed vaginal wall with a piece of material (known as a graft) attached to a ligament along your backbone (or sacrum). These materials are both FDA approved and widely used. The following objectives: anatomic outcomes, graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life, subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy will be evaluated.

The study visits are all under standard of care. Study questionnaires are unique to the study and will be completed at the enrollment in hospital, 2, 6,12 weeks, 6 months and one year visits The questionnaires are related to bowel function, bladder function, prolapse and sexual activity.

Permission will be requested to contact the patient again 5 years after surgery. Contact in the future will in no way obligate the patient to participate.

There may or may not be direct medical benefits to the participant. Decreased risk of erosion may be a possible benefit if placed in the organic "natural" arm of the study. The information learned from this study may benefit other patients in the future

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Status Verified: 2007-11
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Last Update Submitted: 2011-03-21
• Last Update Posted: 2011-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Greater than 18 years of age

Exclusion Criteria

• Prior sacral colpopexy or rectopexy

Contraindication to surgery based on co-existent medical condition

Desire for expectant management or pessary use

Pregnancy or the desire for pregnancy within 24 months of the sacral colpopexy procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy	One year

Trial Locations

Locations (1)

Urogynecology, 95 Madison Ave.; 🇺🇸 Morristown, New Jersey, United States