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Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

This study is currently recruiting participants.
Verified April 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01044589
First received: January 7, 2010
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.


Condition Intervention
Fecal Incontinence
Anal Incontinence
 Device: Biodesign Tissue Repair Graft
Other: Overlapping Sphincter Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Number of incontinence episodes per week [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Quality of Life [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft
 Device: Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft reinforcement
Other: Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone
Active Comparator: Overlapping Sphincter Repair
Control
 Other: Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone

  Eligibility

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

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
  • Fecal incontinence severity score of 10 or more
  • Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria:

  • History of diabetes
  • History of allergy to porcine derivatives
  • History of infection in the anal area (abscess, fistula)
  • History of inflammatory bowel disease
  • History of hidradenitis suppurativa
  • History of immunosuppression
  • History of HIV positivity
  • History of radiation to the study site within the last 12 months
  • Patients who cannot travel to keep follow up appointments
  • Patients who are prisoners
  • Patients who are mentally handicapped
  • Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
  • Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
  • Patients with a FIQL baseline score of ≤ 4
  • Patients participating in another clinical trial for the same indication
  • Patients unwilling to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044589

Contacts
Contact: Jason Hodde 765-497-3355 hodde@cookbiotech.com

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Margaret Terry, LPN, BBA     216-445-4790     TERRYM@ccf.org    
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01044589     History of Changes
Other Study ID Numbers: 09-008
Study First Received: January 7, 2010
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013