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

Phase 1

Completed

Conditions: Fecal Incontinence

Interventions: Device: TOPAS

Registration Number: NCT00565136

Lead Sponsor: ASTORA Women's Health

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 29

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TOPAS	TOPAS	TOPAS AMS Pelvic Floor Repair System

Primary Outcome Measures

Name	Time	Method
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment	Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment	Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.

Secondary Outcome Measures

Name	Time	Method
Intra- and Peri-Surgical Parameters: Length of Procedure	Duration of the device implant procedure
Fecal Incontinence Symptoms as Measured by the Wexner Score	Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment	The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period	Through 24 month post-treatment	Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence	Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment	The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively.
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life	Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment	The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.
Intra- and Peri-Surgical Parameters: Length of Hospital Stay	Length of the hospital stay for the device implant procedure
Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure	Duration of the device implant procedure (an average of 23 minutes)
Pain Intensity as Measured by the Pain Intensity Scale	Baseline (pre-treatment), 6 Week post-treatment	The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.

Trial Locations

Locations (5): Mount Auburn Hospital
🇺🇸
Cambridge, Massachusetts, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
St. Lukes Hospital
🇺🇸
Allentown, Pennsylvania, United States
Sacred Heart Hospital
🇺🇸
Spokane, Washington, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States