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

Official Title:

An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Interventional 18 Years and older ASTORA Women's Health WC0807
NCT01090739
Ongoing but not enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of General Surgery
Chief, Section of Colorectal Surgery 
Maurice Galante, MD Distinguished Professor in Surgical Oncology
Director, UCSF Center for Pelvic Physiology 

For information or patient referral contact:
 

Adriana Chou
2330 Post Street, Suite 260
Box 0144
San Francisco, CA 94143-0144
Voice: 415/353-7252
Fax: 415/885-3886
Adriana.Chou@ucsfmedctr.org


Trial Summary

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.

Eligibility

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.

Detailed Description

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).

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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