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: August 20, 2013
Last verified: August 2013

November 27, 2007
August 20, 2013
September 2007
December 2010   (final data collection date for primary outcome measure)
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.
Changes in fecal incontinence symptoms as measured by a patient bowel diary [ Time Frame: Bowel diary completed before surgery and at 3,6,12 and 24 mos after surgery ]
Complete list of historical versions of study NCT00565136 on ClinicalTrials.gov Archive Site
  • 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 ]
Changes in fecal incontinence symptoms measured by Quality of Life questionnaires [ Time Frame: Questionnaires completed before surgery and at 6 wks and at 3,6, 12 and 24 mos after surgery ]
  • 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.
Not Provided
 
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
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

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fecal Incontinence
Device: TOPAS
A mesh sling permanently implanted to increase pelvic floor support
Experimental: TOPAS
TOPAS AMS Pelvic Floor Repair System
Intervention: Device: TOPAS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
December 2012
December 2010   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00565136
WC0610
No
American Medical Systems
American Medical Systems
Not Provided
Principal Investigator: Anders Mellgren, MD, PhD Abbott Northwestern Medical Center
American Medical Systems
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP