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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontinence Symptoms

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: TOPAS


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOPAS<br>TOPAS AMS Pelvic Floor Repair System | Device: TOPAS<br>* A mesh sling permanently implanted to increase pelvic floor support<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period | 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) | Through 24 month post-treatment | 
| Fecal Incontinence Symptoms as Measured by the Wexner Score | 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | 
| Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence | 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. | Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment | 
| Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life | 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. | Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment | 
| Pain Intensity as Measured by the Pain Intensity Scale | The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale. | Baseline (pre-treatment), 6 Week post-treatment | 
| Intra- and Peri-Surgical Parameters: Length of Procedure |  | Duration of the device implant procedure | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Device study, Pelvic floor weakness, Fecal incontinence