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

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.

• TOPAS (Device): A mesh sling permanently implanted to increase pelvic floor support

Primary outcomes

• 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 outcomes

• 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 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.
• 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.
• 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.
• 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)]

Other outcomes

• Anal Manometry: Maximum Resting Pressure [Baseline (pre-treatment), 6 Month post-treatment]
• Anal Manometry: Maximum Squeeze Pressure [Baseline (pre-treatment), 6 Month post-treatment]
• Anal Manometry: Rectal First Sensation [Baseline (pre-treatment), 6 Month post-treatment]
• Anal Manometry: Maximum Tolerable Volume [Baseline (pre-treatment), 6 Month post-treatment]
• Pudendal Nerve Terminal Motor Latency [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.

Sex: Female, ages: 21 Years to any

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

Participant flow

Outcome results

• Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment (Primary), Mean, Number of FI episodes/14 day period: TOPAS 6.9 +/- 5.1
• Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period (Secondary), Number, events per 24 months/participant: TOPAS 2.34
• Fecal Incontinence Symptoms as Measured by the Wexner Score (Secondary), Mean, units on a scale: TOPAS 13.2 +/- 2.6
• Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence (Secondary), Mean, units on a scale: TOPAS 10.1 +/- 1.4
• Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline (Post hoc), Number, percentage participants: TOPAS 59.3 (41.7 to 75.2)
• Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life (Secondary), Mean, units on a scale: TOPAS 2.7 +/- 0.8
• Pain Intensity as Measured by the Pain Intensity Scale (Secondary), Mean, units on a scale: TOPAS 1.0 +/- 1.5
• Intra- and Peri-Surgical Parameters: Length of Procedure (Secondary), Mean, minutes: TOPAS 23 +/- 8
• Intra- and Peri-Surgical Parameters: Length of Hospital Stay (Secondary), Mean, hours: TOPAS 22.6 +/- 11.6
• Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure (Secondary), Mean, ml: TOPAS 15 +/- 13
• Anal Manometry: Maximum Resting Pressure (Other pre specified), Mean, mmHg: TOPAS 29.2 +/- 23.2
• Anal Manometry: Maximum Squeeze Pressure (Other pre specified), Mean, mmHg: TOPAS 53.2 +/- 38.7
• Anal Manometry: Rectal First Sensation (Other pre specified), Mean, cc: TOPAS 37.6 +/- 22.3
• Anal Manometry: Maximum Tolerable Volume (Other pre specified), Mean, cc: TOPAS 115.3 +/- 52.4
• Pudendal Nerve Terminal Motor Latency (Other pre specified), Mean, msec: TOPAS 3.3 +/- 2.6

Adverse events

Time frame: From implant to 24 months post-treatment

Serious adverse events by term

Other adverse events by term

Limitations and caveats: This study was not powered to statistically evaluate device performance.

• Results publication: Rosenblatt P, Schumacher J, Lucente V, McNevin S, Rafferty J, Mellgren A. A preliminary evaluation of the TOPAS system for the treatment of fecal incontinence in women. Female Pelvic Med Reconstr Surg. 2014 May-Jun;20(3):155-62. doi: 10.1097/SPV.0000000000000080. PMID 24763157

• Anders Mellgren, MD, PhD, Principal investigator, Abbott Northwestern Medical Center