Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
NCT ID: NCT01090739
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
207 participants
INTERVENTIONAL
2010-04-30
2016-04-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TOPAS
TOPAS Treatment for Fecal Incontinence
TOPAS Treatment for Fecal Incontinence
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.
Interventions
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TOPAS Treatment for Fecal Incontinence
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 Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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ASTORA Women's Health
INDUSTRY
Responsible Party
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Principal Investigators
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Anders Mellgren, MD, PhD
Role: STUDY_CHAIR
University of Illinois at Chicago
Dee Fenner, MD
Role: STUDY_CHAIR
University of Michigan
Locations
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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
Weston, Florida, United States
Raybon OB-GYN
Toccoa, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Atlantic Health System
Morristown, New Jersey, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation - Ohio
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
St. Luke's Hospital
Allentown, Pennsylvania, United States
Womens Hospital of Texas
Houston, Texas, United States
Sacred Heart Medical Center
Spokane, Washington, United States
Countries
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References
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Mellgren A, Zutshi M, Lucente VR, Culligan P, Fenner DE; TOPAS Study Group. A posterior anal sling for fecal incontinence: results of a 152-patient prospective multicenter study. Am J Obstet Gynecol. 2016 Mar;214(3):349.e1-8. doi: 10.1016/j.ajog.2015.10.013. Epub 2015 Oct 19.
Related Links
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Primary (1 Year) Results Manuscript
Other Identifiers
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WC0807
Identifier Type: -
Identifier Source: org_study_id
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