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

Primary Purpose

Fecal Incontinence

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TOPAS

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Device study, Pelvic floor weakness, Fecal incontinence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mount Auburn Hospital
University of Minnesota
The Christ Hospital
St. Lukes Hospital
Sacred Heart Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TOPAS

Arm Description

TOPAS AMS Pelvic Floor Repair System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

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.

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.

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.

Intra- and Peri-Surgical Parameters: Length of Procedure

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

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

Full Information

NCT ID

NCT00565136

First Posted

November 27, 2007

Last Updated

April 21, 2016

Sponsor

ASTORA Women's Health

1. Study Identification

Unique Protocol Identification Number

NCT00565136

Brief Title

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

Acronym

TOPAS

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ASTORA Women's Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

Keywords

Device study, Pelvic floor weakness, Fecal incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TOPAS

Arm Type

Experimental

Arm Description

TOPAS AMS Pelvic Floor Repair System

Intervention Type

Device

Intervention Name(s)

TOPAS

Intervention Description

A mesh sling permanently implanted to increase pelvic floor support

Primary Outcome Measure Information:

Title

Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment

Description

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.

Time Frame

Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

Secondary Outcome Measure Information:

Title

Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period

Description

Time Frame

Through 24 month post-treatment

Title

Fecal Incontinence Symptoms as Measured by the Wexner Score

Description

Time Frame

Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

Title

Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence

Description

Time Frame

Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment

Title

Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life

Description

Time Frame

Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment

Title

Pain Intensity as Measured by the Pain Intensity Scale

Description

The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.

Time Frame

Baseline (pre-treatment), 6 Week post-treatment

Title

Intra- and Peri-Surgical Parameters: Length of Procedure

Time Frame

Duration of the device implant procedure

Title

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

Time Frame

Length of the hospital stay for the device implant procedure

Title

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 Pre-specified Outcome Measures:

Title

Anal Manometry: Maximum Resting Pressure

Time Frame