Anal Incontinence, Fecal Incontinence
Conditions
Brief 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.
Interventions
DEVICEBiodesign Tissue Repair Graft
Biodesign Tissue Repair Graft reinforcement
OTHEROverlapping Sphincter Repair
Overlapping Sphincter Repair Alone
Sponsors
Cook Group Incorporated
Massarat Zutshi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 24 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overlapping Sphincter Repair Control
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone | 6 |
| Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement
Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Overlapping Sphincter Repair | Biodesign Tissue Repair Graft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 1 / 7 |
Outcome results
Primary
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overlapping Sphincter Repair | Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 2 Participants |
| Biodesign Tissue Repair Graft | Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 2 Participants |
Secondary
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overlapping Sphincter Repair | Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 1 Participants |
| Biodesign Tissue Repair Graft | Number of Participants Reporting a Decrease in Incontinence Episodes Per Week | 1 Participants |