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

Fecal Incontinence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044589
• Other study ID #: 09-008
• Status: Completed
• Phase: N/A
• First received: January 7, 2010
• Last updated: April 17, 2017
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence

Intervention

Device:
• Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft reinforcement

Other:
• Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Massarat Zutshi	Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incontinence episodes per week		12 months
Secondary	Change in Quality of Life		24 months