Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence

ASTORA Women's Health207 enrolled

Overview

The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.

This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist. This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

207

Conditions

Fecal Incontinence

Interventions

TOPAS Treatment for Fecal IncontinenceDEVICE

The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Subject is/has: 1. An adult (\>/= 18 years) female. 2. FI symptoms for a minimum of 6 months. 3. Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training. 4. \<50 years old OR if \>/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines). 5. FI episodes ≥ 4 in 14 day period. Exclusion Criteria: Subject is/has 1. Unable or unwilling to sign Informed Consent Form or comply with study requirements. 2. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS. 3. Allergic to polypropylene. 4. Pregnant or planning a future pregnancy. 5. Less than 12 months (365 days) postpartum. 6. Pelvic prolapse \>/=1 cm beyond the hymen (Stage III \& IV) 7. Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation. 8. Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation. 9. Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation. 10. Planning pelvic surgery within 12 months (365 days) post implant 11. Current Grade III or IV hemorrhoids. 12. Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor. 13. Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease). 14. Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. 15. Severe chronic constipation, including obstructive defecatory disorder. 16. External full thickness rectal prolapse. 17. A history of laxative abuse within the past 5 years. 18. Had previous rectal resection. 19. Active pelvic infection, perianal or recto-vaginal fistula. 20. Congenital anorectal malformations or chronic 4th degree lacerations and cloacae. 21. History of therapeutic radiation for cancers of the pelvis. 22. Currently implanted with a sacral nerve stimulator. 23. Contraindicated for surgery or having any condition that would compromise wound healing.

Locations (14)

University of California SF - Mt Zion Medical Center

San Francisco, California, United States

University of South Florida

Tampa, Florida, United States

Cleveland Clinic Foundation - Florida

Outcomes

Primary Outcomes

Percentage of Responders

The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.

Time frame: 12 Months

Secondary Outcomes

Change in Fecal Incontinence Episodes

Number of fecal incontinence episodes in a 14 day period

Time frame: 36 Month Follow-up Visit

Change in Fecal Incontinence Days

Number of fecal incontinence days in a 14 day period

Time frame: 36 Month Follow-up Visit

Change in Urge Fecal Incontinence Episodes

Number of urge fecal incontinence episodes in a 14 day period

Time frame: 36 Month Follow-up Visit

Change in Wexner Symptom Severity Score

Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.

Time frame: 36 Month Follow-up Visit

Change in Fecal Incontinence Quality of Life Score

Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (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). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.

Data from ClinicalTrials.gov

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