Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms (TOPAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||December 2010|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|