Treatment of Patients With Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT00292318|
Recruitment Status : Terminated (Unable to continue due to medical equipment necessary for research study was removed from facility.)
First Posted : February 15, 2006
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Behavioral: Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study Behavioral: control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Biofeedback Therapy for Fecal Incontinence a Randomized Control Trial|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2014|
Active Comparator: Arm 1
Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.
Behavioral: control group
Medical counseling and ano-sphinctal exercises.
Experimental: Arm 2
Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.
Behavioral: Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study
Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem.
- Patient Report of "Adequate Relief" From FI Symptoms With a "Yes" Answer Will be Used as Primary Outcome Variable. Data Will be Recorded at End of Treatment. A "Responder" Will be Defined as One Who Provides a "Yes" Answer. [ Time Frame: The primary outcome will be determined at the end of the study which will be 20 weeks after starting the study. ]Only reporting the results of participants who reported adequate relief.
- Change in Anorectal Physiologic Tests (Absolute Squeeze Pressure) [ Time Frame: The secondary outcome will be determined at the end of the study which will be 20 weeks after starting the study. ]Measurement of pressure changes by a colonoscope as recorded by a manometric catheter connected to a Polygraph transducer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292318
|United States, California|
|VA Greater Los Angeles Healthcare System, Sepulveda, CA|
|Sepulveda, California, United States, 91343|
|Principal Investigator:||Felix W Leung, MD||VA Greater Los Angeles Healthcare System, Sepulveda, CA|