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

• Sponsor: Atlantic Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT00564083
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Duration (Months): 54
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Prolapse	Procedure: sacral colpopexy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Outcome Measures

Primary Outcome Measures

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 [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urogynecology, 95 Madison Ave.	Morristown	New Jersey	United States	07960

Sponsors and Collaborators

• Atlantic Health System

Investigators

• Principal Investigator: Patrick Culligan, MD, Atlantic Health Urogynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00564083
• Other Study ID Numbers: BARD
• First Posted: Nov 27, 2007
• Last Update Posted: Mar 22, 2011
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: Compare the relative differences between the organic and sythentic materials for sacryl colpopexy.
• Additional relevant MeSH terms: Uterine Prolapse; Prolapse

Study Results

No Results Posted as of Mar 22, 2011