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Arm 2 for Bowel Incontinence
N/A
Waitlist Available
Led By Felix W Leung, MD
Research Sponsored by US Department of Veterans Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary outcome will be determined at the end of the study which will be 20 weeks after starting the study.
Awards & highlights
Summary
The purpose of this study is to determine if a behavioral treatment method called biofeedback will reduce the frequency of episodes of leakage of fecal material in patient suffering from fecal incontinence.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer.
Secondary outcome measures
Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment1 Intervention
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Group II: Arm 1Active Control1 Intervention
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
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Who is running the clinical trial?
US Department of Veterans AffairsLead Sponsor
872 Previous Clinical Trials
497,982 Total Patients Enrolled
Felix W Leung, MDPrincipal InvestigatorVA Greater Los Angeles Healthcare System, Sepulveda, CA
3 Previous Clinical Trials
1,968 Total Patients Enrolled
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