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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Detailed Description

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This is a multi-center study under a common protocol. 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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOPAS

TOPAS AMS Pelvic Floor Repair System

Group Type EXPERIMENTAL

TOPAS

Intervention Type DEVICE

A mesh sling permanently implanted to increase pelvic floor support

Interventions

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TOPAS

A mesh sling permanently implanted to increase pelvic floor support

Intervention Type DEVICE

Eligibility Criteria

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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 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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No