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

NCT00565136 | Completed Phase 1 Results

• 1 other identifier: WC0610
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

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

Conditions

Fecal Incontinence

Keywords

Device study; Pelvic floor weakness; Fecal incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Through 24 month post-treatment

• Fecal Incontinence Symptoms as Measured by the Wexner Score

  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

  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

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

• Pain Intensity as Measured by the Pain Intensity Scale

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

Other Outcomes (5)

• 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

Study Arms (1)

TOPAS

EXPERIMENTAL

TOPAS AMS Pelvic Floor Repair System

Device: TOPAS

Interventions

TOPAS DEVICE

A mesh sling permanently implanted to increase pelvic floor support

TOPAS

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (5)

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

St. Lukes Hospital

Allentown, Pennsylvania, 97205, United States

Location

Sacred Heart Hospital

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 24763157 RESULT

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Limitations and Caveats

This study was not powered to statistically evaluate device performance.

Results Point of Contact

• Title: Peter Rosenblatt, MD; Director of Urogynecology
• Organization: Boston Urogynecology Associates

prosenbl@mah.harvard.edu

(617) 354-5452

Study Officials

• Anders Mellgren, MD, PhD

  Abbott Northwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 23, 2016
• Results First Posted: August 22, 2013

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)