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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT01090739
First received: March 19, 2010
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Fecal Incontinence
Device: TOPAS Sling System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 success.


Enrollment: 152
Study Start Date: April 2010
Estimated Study Completion Date: December 2017
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOPAS
TOPAS Sling System Implant
Device: TOPAS Sling System
The TOPAS Sling System 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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090739

Locations
United States, California
University of California SF - Mt Zion Medical Center
San Francisco, California, United States, 94115
United States, Florida
University of South Florida
Tampa, Florida, United States, 33605
Cleveland Clinic Foundation - Florida
Weston, Florida, United States, 33331
United States, Georgia
Raybon OB-GYN
Toccoa, Georgia, United States, 30577
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Atlantic Health System
Morristown, New Jersey, United States, 07960
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation - Ohio
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 76104
United States, Pennsylvania
St. Luke's Hospital
Allentown, Pennsylvania, United States, 18104
United States, Texas
Womens Hospital of Texas
Houston, Texas, United States, 77054
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
American Medical Systems
Investigators
Study Chair: Anders Mellgren, MD, PhD University of Illinois at Chicago
Study Chair: Dee Fenner, MD University of Michigan
  More Information

Additional Information:
No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT01090739     History of Changes
Other Study ID Numbers: WC0807
Study First Received: March 19, 2010
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by American Medical Systems:
Fecal Incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014