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

NCT00564083 | Completed

• 1 other identifier: BARD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Uterine Prolapse

Keywords

Compare the relative differences between the organic and sythentic materials for sacryl colpopexy.

Outcome Measures

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

  One year

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Urogynecology, 95 Madison Ave.

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

• Culligan PJ, Salamon C, Priestley JL, Shariati A. Porcine dermis compared with polypropylene mesh for laparoscopic sacrocolpopexy: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):143-51. doi: 10.1097/aog.0b013e31827558dc.

  PMID: 23262939 DERIVED

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Culligan, MD

  Atlantic Health Urogynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 27, 2007
• Study Start: December 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 22, 2011

Record last verified: 2007-11

Locations

US (1)