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

NCT00564083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-03-22

No results posted yet for this study

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

Conditions

  • Uterine Prolapse

Interventions

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)

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Patrick Culligan, MD · Atlantic Health Urogynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00564083 on ClinicalTrials.gov