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

Astora Women's Health

Status and phase

Completed

Phase 2

Phase 1

Conditions

Fecal Incontinence

Treatments

Device: TOPAS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00565136

WC0610

Details and patient eligibility

About

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

Full description

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.

Enrollment

29 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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