Home Versus Office Biofeedback Therapy for Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT03216291|
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Behavioral: biofeedback therapy Device: Home Biofeedback therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Everyone is masked to the assignment of home or office biofeedback training. Once the subject makes it to their treatment session, then everyone will know which one the subject has been allocated to.|
|Official Title:||Home Versus Office Biofeedback Therapy for Fecal Incontinence|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Home Biofeedback
Patients will be given home biofeedback device (InTone) to take home and practice biofeedback exercises at least twice a day for six weeks of therapy. Intervention: Home device biofeedback training.
Device: Home Biofeedback therapy
Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems, but instead of an office therapy, the subject will use a biofeedback device to gain strength in their anorectal muscles. This device will be taught how to use in the first session and then the subject will take it home to complete at least 1 session a day for 6 weeks.
Active Comparator: Office biofeedback
Patients with fecal incontinence will receive traditional office biofeedback, once weekly, over six weeks. Intervention: Regular office biofeedback training with assistance of biofeedback person..
Behavioral: biofeedback therapy
Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems. Complete training sessions once a week for 6 weeks in the office.
Other Name: Training
- number of episodes of fecal incontinence [ Time Frame: six weeks ]Assess the change in the No of FI episodes between baseline week and end of study week and compare between the two treatment groups
- Squeeze anal sphincter pressure [ Time Frame: six weeks ]assess the change in anal squeeze sphincter pressure (mm Hg) between baseline anorectal manometry study and study done at the end of treatment and compare between the 2 treatment groups
- Overall quality of life and symptom perception on previously validated Fecal Incontinence questionnaires [ Time Frame: six weeks ]assess the change in 4 quality of life domains between baseline SF-11 survey and survey done at the end of treatment and compare between the 2 treatment groups
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): NCT03216291
|Contact: Satish Rao, MD, PhDemail@example.com|
|Contact: Rachael Parr, MPHfirstname.lastname@example.org|
|United States, Georgia|
|Augusta, Georgia, United States, 30907|
|Contact: Ijeoma Azih, MBBS 706-721-1968 email@example.com|
|Principal Investigator: Satish SC Rao, MD, PhD|