Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms (TOPAS)
|ClinicalTrials.gov Identifier: NCT00565136|
Recruitment Status : Completed
First Posted : November 29, 2007
Results First Posted : August 22, 2013
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: TOPAS||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2012|
TOPAS AMS Pelvic Floor Repair System
A mesh sling permanently implanted to increase pelvic floor support
- Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment [ Time Frame: 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.
- Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period [ Time Frame: 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 the Wexner Score [ Time Frame: 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.
- Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence [ Time Frame: 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 [ Time Frame: 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.
- Pain Intensity as Measured by the Pain Intensity Scale [ Time Frame: 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.
- 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) ]
- Anal Manometry: Maximum Resting Pressure [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]
- Anal Manometry: Maximum Squeeze Pressure [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]
- Anal Manometry: Rectal First Sensation [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]
- Anal Manometry: Maximum Tolerable Volume [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]
- Pudendal Nerve Terminal Motor Latency [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ]Pudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565136
|United States, Massachusetts|
|Mount Auburn Hospital|
|Cambridge, Massachusetts, United States, 02138|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|United States, Ohio|
|The Christ Hospital|
|Cincinnati, Ohio, United States, 45219|
|United States, Pennsylvania|
|St. Lukes Hospital|
|Allentown, Pennsylvania, United States, 97205|
|United States, Washington|
|Sacred Heart Hospital|
|Spokane, Washington, United States, 99204|
|Principal Investigator:||Anders Mellgren, MD, PhD||Abbott Northwestern Medical Center|