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

Study Overview
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Brief Summary
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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

Conditions
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Uterine Prolapse

Intervention / Treatment
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* Procedure: sacral colpopexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compare the relative differences between the organic and sythentic materials for sacryl colpopexy.