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Sponsored by: |
Atlantic Health System |
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Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00564083 |
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 | Intervention |
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Uterine Prolapse |
Procedure: sacral colpopexy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Factorial Assignment |
Estimated Enrollment: | 120 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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
Contact: Janet Scherer, RN, BSN | 973-971-7424 | janet.sherer@atlantichhealth.org |
United States, New Jersey | |
Urogynecology, 95 Madison Ave. | Recruiting |
Morristown, New Jersey, United States, 07960 | |
Contact: Janet Scherer, RN, BSN 973-971-7424 janet.scherer@atlantichhealth.org |
Principal Investigator: | Patrick Culligan, MD | Atlantic Health Urogynecology |
Study ID Numbers: | BARD |
Study First Received: | November 26, 2007 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00564083 |
Health Authority: | United States: Institutional Review Board |
Compare the relative differences between the organic and sythentic materials for sacryl colpopexy. |
Genital Diseases, Female Pathological Conditions, Anatomical Uterine Prolapse Uterine Diseases Prolapse |