Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms - Full Text View

Sponsored by:	American Medical Systems
Information provided by:	American Medical Systems
ClinicalTrials.gov Identifier:	NCT00565136

Purpose

The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence

Condition	Intervention	Phase
Pelvic Floor Weakness	Device: TOPAS	Phase I Phase II

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontienence Symptoms

Further study details as provided by American Medical Systems:

Primary Outcome Measures:

Changes in fecal incontinence symptoms as measured by patient bowel diary [ Time Frame: Before implantation and 3, 6, 12, and 24 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Quality of Life measured by disease specific tool [ Time Frame: Before implantation and 3,6,12, and 24 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental This study utilizes a single arm.	Device: TOPAS A mesh sling permanently implanted to increase pelvic floor support

Detailed Description:

This is a multi-center pilot study under a common protocol using FDA 510k cleared device. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.

Eligibility

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

Criteria

Inclusion Criteria:

Females at least 21 years of age who have evidence of pelvic floor weakness
Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc.
Subjects, who have an external anal injury, must have some voluntary sphincter control

Exclusion Criteria:

Subjects who are unwilling or unable to sign an Informed Consent form
Subjects who are currently pregnant or considering future child-bearing
Subjects who are contraindicated for surgery
Subjects who are allergic to polypropylene mesh
Subjects who are enrolled in a concurrent clinical trial
Subjects with previous implantation of mesh or trauma to the pelvic area
Subjects who engage in anal receptive intercourse
Subjects with a significant evacuation disorder such as chronic constipation
Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence
Subjects who had a hysterectomy within 6 months prior to enrollment
Subjects with vaginal prolapse that passes the hymen
Subjects with complete rectal prolapse
Subjects with a history of pelvic radiation that compromises the anal canal
Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence
Subjects with a neurological disorder such as ALS, MS, brain tumor as a possible cause for fecal incontinence symptoms
Subjects with an active pelvic infection or a recto-vaginal fistula
Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment
Subjects who have other inappropriate conditions as determined by the physician

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565136

Locations

United States, Massachusetts
Mount Auburn Hospital
Cambridge, Massachusetts, United States, 02138
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
St. Lukes Hospital
Allentown, Pennsylvania, United States, 97205
United States, Washington
Sacred Heart Hospital
Spokane, Washington, United States, 99204

Sponsors and Collaborators

American Medical Systems

Investigators

Principal Investigator:

Anders Mellgren, MD

University of Minnesota

More Information

Responsible Party:	American Medical Systems ( Janet DeMarchi, Clinical Research Specialist )
Study ID Numbers:	WC0610
Study First Received:	November 27, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00565136
Health Authority:	United States: Institutional Review Board

Keywords provided by American Medical Systems:

Device study
Pelvic floor weakness
Fecal incontinence

Study placed in the following topic categories:

Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Asthenia

Urinary Incontinence
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on January 15, 2009