Efficacy Study of Vaginal Mesh for Prolapse - Full Text View

Sponsor:	Medstar Research Institute
Collaborator:	Washington Hospital Center
Information provided by:	Medstar Research Institute
ClinicalTrials.gov Identifier:	NCT00475540

Purpose

The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.

Condition	Intervention	Phase
Pelvic Organ Prolapse Uterine Prolapse Vaginal Prolapse Cystocele Rectocele	Device: synthetic monofilament polypropylene mesh	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Bio-equivalence Study
Official Title:	A Randomized Clinical Trial of Vaginal Mesh for Prolapse

Resource links provided by NLM:

MedlinePlus related topics: Bladder Diseases Pelvic Support Problems

U.S. FDA Resources

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:

All POPQ points (Ba, Bp or C) at Stage I (defined as descent of the leading edge to >1 cm above hymen) or less at one year. [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare patient satisfaction and Quality of Life (QOL) variables between the two arms of the trial. We will also assess complications and subjective cure rates of overall incontinence and lower urinary tract function. [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Prolift mesh: Active Comparator vaginal prolapse repair with mesh	Device: synthetic monofilament polypropylene mesh Vaginal prolapse repair with mesh
Prolapse repair without mesh: Active Comparator vaginal prolapse repair without mesh	Device: synthetic monofilament polypropylene mesh Vaginal prolapse repair with mesh

Detailed Description:

Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Woman > 21 yrs
Stage II-IV vaginal prolapse
Desires vaginal reconstructive surgery
Able to complete study questionnaires and assessments
Uterus < 12 weeks size
Available for 12 months follow-up

Exclusion Criteria:

Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
Current intermittent catheterization.
Pregnancy or desire for future fertility.
Presence of an adnexal mass.
Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).
Other laparoscopic or abdominal/pelvic surgery in the past 3 months.
Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury.
Need for concomitant surgery requiring an abdominal incision.
< 12 months post-partum.
Non-english speaking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475540

Locations

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Medstar Research Institute

Washington Hospital Center

Investigators

Principal Investigator:

Cheryl Iglesia, MD

Washington Hospital Center

More Information

No publications provided

Responsible Party:	Washington Hospital Center ( Cheryl Iglesia, MD )
Study ID Numbers:	2006-232
Study First Received:	May 17, 2007
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00475540 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medstar Research Institute:

prolapse
uterus
pelvic organ
vaginal prolpase

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Rectocele
Cystocele
Uterine Prolapse
Gastrointestinal Diseases
Urinary Bladder Diseases
Uterine Diseases

Intestinal Diseases
Prolapse
Rectal Diseases
Genital Diseases, Female
Digestive System Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 08, 2010