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Completed

NCT Number: NCT00565136

Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS 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

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mount Auburn Hospital, Cambridge, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TOPAS

Device

A mesh sling permanently implanted to increase pelvic floor support

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Intra- and Peri-Surgical Parameters: Length of Procedure

    Time frame: Duration of the device implant procedure

  7. Intra- and Peri-Surgical Parameters: Length of Hospital Stay

    Time frame: Length of the hospital stay for the device implant procedure

  8. Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure

    Time frame: Duration of the device implant procedure (an average of 23 minutes)

Other outcomes

  1. Anal Manometry: Maximum Resting Pressure

    Time frame: Baseline (pre-treatment), 6 Month post-treatment

  2. Anal Manometry: Maximum Squeeze Pressure

    Time frame: Baseline (pre-treatment), 6 Month post-treatment

  3. Anal Manometry: Rectal First Sensation

    Time frame: Baseline (pre-treatment), 6 Month post-treatment

  4. Anal Manometry: Maximum Tolerable Volume

    Time frame: Baseline (pre-treatment), 6 Month post-treatment

  5. 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.

Sponsors and collaborators

Lead sponsor

ASTORA Women's Health

Industry

Registry information

Official study title

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

Acronym: TOPAS

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Nov 29, 2007
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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