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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
A mesh sling permanently implanted to increase pelvic floor support
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
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.
Time frame: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
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)
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sacred Heart Hospital
Spokane, Washington, United States
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-treatment), 6 Week post-treatment
Intra- and Peri-Surgical Parameters: Length of Procedure
Time frame: Duration of the device implant procedure
Intra- and Peri-Surgical Parameters: Length of Hospital Stay
Time frame: Length of the hospital stay for the device implant procedure
Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure
Time frame: Duration of the device implant procedure (an average of 23 minutes)