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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00565136
First received: November 27, 2007
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Fecal Incontinence
Device: TOPAS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period [ Time Frame: Through 24 month post-treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Intra- and Peri-Surgical Parameters: Length of Hospital Stay [ Time Frame: Length of the hospital stay for the device implant procedure ] [ Designated as safety issue: No ]
  • Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure [ Time Frame: Duration of the device implant procedure (an average of 23 minutes) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Anal Manometry: Maximum Resting Pressure [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ] [ Designated as safety issue: No ]
  • Anal Manometry: Maximum Squeeze Pressure [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ] [ Designated as safety issue: No ]
  • Anal Manometry: Rectal First Sensation [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ] [ Designated as safety issue: No ]
  • Anal Manometry: Maximum Tolerable Volume [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ] [ Designated as safety issue: No ]
  • Pudendal Nerve Terminal Motor Latency [ Time Frame: Baseline (pre-treatment), 6 Month post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: September 2007
Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOPAS
TOPAS AMS Pelvic Floor Repair System
Device: TOPAS
A mesh sling permanently implanted to increase pelvic floor support

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565136

Locations
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
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Anders Mellgren, MD, PhD Abbott Northwestern Medical Center
  More Information

Publications:
Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00565136     History of Changes
Other Study ID Numbers: WC0610
Study First Received: November 27, 2007
Results First Received: May 1, 2013
Last Updated: June 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by American Medical Systems:
Device study
Pelvic floor weakness
Fecal incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 29, 2014