RecruitingNot ApplicableNCT05771597

Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence

Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study


Sponsor

Augusta University

Enrollment

72 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies. The purpose of this study is to 1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system 2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy 3. To assess the cost-effectiveness of home biofeedback therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new wireless, app-based home biofeedback therapy system against standard office-based biofeedback for three common pelvic floor conditions: dyssynergic defecation (difficulty emptying the bowel due to muscle coordination problems), fecal incontinence (stool leakage), and urinary incontinence (urine leakage). The home system uses a Bluetooth-connected probe and a smartphone app with animated visuals and voice guidance to let patients practice pelvic floor exercises at home. Adults aged 18 and older with one of the three qualifying conditions (confirmed by specific diagnostic criteria) who do not have severe heart or kidney disease, active bowel disease, or pregnancy are eligible. Participation involves using either the home device or attending standard clinic sessions for several weeks, plus filling out symptom questionnaires and completing follow-up assessments. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHome Biofeedback therapy

Patients will be given home biofeedback device to take home and practice biofeedback exercises at least twice a day for six weeks of therapy. 1. HBT for patients with constipation and dyssynergic defecation: Patients will attend one session of training on how to use the device followed by daily sessions at home for 6 weeks. After placing a probe into rectum, the patient sits on a commode, activates the smart phone app and follow the voice-guided instructions to perform diaphragmatic breathing exercises and push maneuvers with/without balloon distension. 2. HBT for patients with FI: Subject will receive training on how to use the home-trainer device and probe placement. The patient will be asked to follow a series of voice guided instructions consisting of performing short and long duration squeeze maneuvers over 25 minutes. 3. HBT for patients with UI: The instructions protocol as written above for patients with FI will be followed for UI patients as well.

OTHEROffice biofeedback therapy

Patients will receive traditional office biofeedback, once weekly, over six weeks. 1. OBT for patients with constipation and dyssynergic defecation: The patient will receive instructions on the diaphragmatic breathing techniques. Then the patient sits on a commode, coordination between push effort and the anal and pelvic floor relaxation is corrected by the therapist. The patients will receive visual and verbal feedback instructions from the therapist. 2. OBT for patients with FI: Patients will be taught Kegels and abdominal muscle exercises. Visual and verbal feedback techniques are used to reinforce the maneuvers. The patient is instructed to squeeze and to maintain this squeeze for as long as possible. 3. OBT for patients with UI: Biofeedback training is performed using the protocol and objectives as described above for FI training.


Locations(1)

Augusta University

Augusta, Georgia, United States

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NCT05771597


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