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OpenTrials
Completed

NCT Number: NCT00564083

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Urogynecology, 95 Madison Ave.

Morristown, New Jersey, 07960, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacral colpopexy

Procedure

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)

Primary outcomes

  1. 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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Nov 27, 2007
Registry last updated
Mar 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.