Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms

Completed · Phase 1/Phase 2

Conditions studied: Fecal Incontinence

In brief

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

Key facts

Study ID

NCT00565136

Run by

ASTORA Women's Health

People needed

29

Starts

2007-09-01

Expected to finish

2012-12-01

Last updated by the study team

2016-05-23

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 amyotrophic lateral sclerosis, multiple sclerosis, or 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

Where it is running

• Mount Auburn Hospital — Cambridge, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• St. Lukes Hospital — Allentown, Pennsylvania, United States
• Sacred Heart Hospital — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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