Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
This study is ongoing, but not recruiting participants.
Sponsor:
American Medical Systems
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00565136
First received: November 27, 2007
Last updated: August 6, 2012
Last verified: August 2012
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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:
- Change in fecal incontinence incidences, including solid and liquid stools, as measured by the mean rate obtained using a three week bowel diary [ Time Frame: Baseline (pre-treatment) and at 3 months post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence rate of complications [ Time Frame: Baseline and 6 weeks and 3, 6, 12, and 24 months post-treatment ] [ Designated as safety issue: Yes ]
- Fecal incontinence symptoms as measured by Wexner Scores and Symptom Severity Scale in Fecal Incontinence (SSSFI) [ Time Frame: Baseline and 6 weeks and 3, 6, 12, and 24 months post-treatment ] [ Designated as safety issue: No ]
Wexner Score as published: Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97
SSSFI Score as published: Bharucha AE, Locke GR 3rd, Seide BM, Zinsmeister AR. A new questionnaire for constipation and faecal incontinence. Aliment Pharmacol Ther. 2004 Aug 1;20(3):355-64.
- Quality of life assessments as measured by the Fecal Incontinence Quality of Life (FIQOL) scale [ Time Frame: Baseline and 3, 6, 12, and 24 months post-treatment ] [ Designated as safety issue: No ]FIQOL Scale as published: Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7.
- Changes in pain as measured by the Pain Intensity Scale [ Time Frame: Baseline and 6 weeks post-treatment ] [ Designated as safety issue: No ]Pain Intesity Scale as published: McCafferty M, Beebe A. Pain: Clinical Manual for Nursing Practice. Baltimore: V.V. Mosby Company, 1993.
- Intra- and peri-surgical parameters [ Time Frame: Implantation ] [ Designated as safety issue: Yes ]
- Length of procedure
- Length of hospital stay
- Amount of the blood loss during the procedure
| Enrollment: | 29 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | August 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 ALS, MS, 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
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
No publications provided
| Responsible Party: | American Medical Systems |
| ClinicalTrials.gov Identifier: | NCT00565136 History of Changes |
| Other Study ID Numbers: | WC0610 |
| Study First Received: | November 27, 2007 |
| Last Updated: | August 6, 2012 |
| 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 May 22, 2013