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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT05771597
Status
Recruiting
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Conditions

  • Dyssynergic Defecation
  • Fecal Incontinence
  • Urinary Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home Biofeedback therapy — OTHER
    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.
  • Office biofeedback therapy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Mar 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Home Biofeedback Therapy (HBT)
    1. HBT for patients with constipation and dyssynergic defecation: 2. HBT for patients with FI 3. HBT for patients with UI All patients will be advised to practice HBT at least once or twice a day for six weeks.
  • Active Comparator: Office Biofeedback Therapy (OBT)
    1. OBT for patients with constipation and dyssynergic defecation. 2. OBT for patients with FI. 3. OBT for patients with UI. All patients will receive office biofeedback, once weekly, over six weeks.

Primary Outcome Measure

The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation [ Time Frame: 6 weeks (short term) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Augusta UniversityAugustaGeorgia30912
Satish Rao, MD, PhD
[email protected]
706-721-2239
Bianca Marsh, BS
[email protected]
706-446-5765

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