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

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

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

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: TOPAS

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 97205
      • St. Lukes Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOPAS; TOPAS AMS Pelvic Floor Repair System	Device: TOPAS; A mesh sling permanently implanted to increase pelvic floor support

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline (pre-treatment), 6 Month post-treatment

Collaborators and Investigators

• Sponsor: ASTORA Women's Health
• Investigators: Principal Investigator: Anders Mellgren, MD, PhD, Abbott Northwestern Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 27, 2007
• First Submitted That Met QC Criteria: November 27, 2007
• First Posted (Estimate): November 29, 2007

Study Record Updates

• Last Update Posted (Estimate): May 23, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Fecal incontinence; Device study; Pelvic floor weakness
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: WC0610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO