Study Summary
This trial is testing a new treatment for fecal incontinence. Patients will either receive injections of a bulking agent or biofeedback, and will be monitored for a 75% reduction in fecal incontinence episodes. If the treatment is successful, participants will be followed for an additional 21 months.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 7 Secondary · Reporting Duration: up to 24 months
3-month follow-up
Proportion of Participants with Specified Adverse Events at Month 3 Follow-Up
Treatment Costs at Month 3 Follow-Up
Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline
up to 24 months
Change in Psychological Distress as Assessed Using the 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Change in Psychological Distress as Assessed Using the 8-item PROMIS Depression Scale
Change in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale
Change in Quality of Life as Assessed Using the Fecal Incontinence Quality of Life Scale
Change in the Severity of FI as Assessed Using the Fecal Incontinence Severity Scale
Number of Participants with Reduction of 50% or More in Average Weekly FI Episodes
Proportion of Participants Who are Continent
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Biofeedback (BIO)
1 of 2
Injection (INJ)
1 of 2
Active Control
285 Total Participants · 2 Treatment Groups
Primary Treatment: Biofeedback (BIO) · No Placebo Group · N/A
Biofeedback (BIO)
Behavioral
ActiveComparator Group · 1 Intervention: Biofeedback · Intervention Types: BehavioralInjection (INJ)
Device
ActiveComparator Group · 1 Intervention: Injection · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
Mayo ClinicOTHER
2,917 Previous Clinical Trials
3,506,603 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,141 Previous Clinical Trials
4,064,190 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,367 Previous Clinical Trials
3,919,396 Total Patients Enrolled
Colon and Rectal Surgery Associates, Ltd.OTHER
2 Previous Clinical Trials
224 Total Patients Enrolled
RTI InternationalOTHER
156 Previous Clinical Trials
753,204 Total Patients Enrolled
Augusta UniversityOTHER
193 Previous Clinical Trials
73,876 Total Patients Enrolled
William Whitehead, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:After 4 weeks of conservative treatment, there has been less than a 75% reduction in the number of FI episodes.
The text refers to a medical condition that can be treated with dextranomer
The physician has diagnosed the individual with FI for the past six months or longer.
Can walk independently on flat surfaces, but may need help from devices other than parallel bars.
People who stained themselves more than two times a week, both by self-report and during the two-week baseline, tended to have more liquid FI episodes.
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Conditions
Cancer Related
Treatments