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

Phase

N/A

Condition

Urinary Incontinence

Fecal Incontinence

Enuresis

Treatment

N/A

Clinical Study ID

NCT05771597

1739484

Ages > 18
All Genders

Study 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

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
To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy
To assess the cost-effectiveness of home biofeedback therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Inclusion Criteria for patients with constipation and dyssynergic defecation

Minimum age of 18 years
Meet Rome IV criteria for functional constipation (≥ 2 of following 6 symptoms)with symptom onset of 6 months on prospective stool diary

Straining with 25% of bowel movements (BM)
Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM
Sensation of incomplete evacuation with 25% of BM
Sensation of anorectal obstruction/blockage with 25% of BM
Manual maneuvers to facilitate defecation with 25% of BM
< 3 Spontaneous bowel movements per week 3. Patients must demonstrate dyssynergicpattern of defecation (Types I-IV), during repeated attempts to defecate, and definedas a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forcesduring anorectal manometry.
Dyssynergic pattern of defecation on anorectal manometry plus one or more of thefollowing criteria:
Inability to expel an artificial stool (50 mL water-filled balloon) within 1minute.
Prolonged colonic transit time on wireless motility capsule (>59 hours) or >5markers retained on a colonic transit study.
Inability to evacuate or ≥ 50% retention of barium during defecography. Inclusion Criteria for patients with fecal incontinence

Minimum age of 18 years
Recurrent episodes of fecal incontinence for six months
No colonic mucosal disease
On a two-week, prospective stool diary, patient reports at least one episode of fecalincontinence per week Inclusion Criteria for patients with urinary incontinence
Minimum age of 18 years
Recurrent episodes of urinary incontinence for three months
Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinaryincontinence on a 14-day urinary incontinence diary

Exclusion

Exclusion Criteria:

Exclusion criteria for patients with constipation and dyssynergic defecation

Evidence of structural or metabolic disease that could cause constipation, asassessed by colonoscopy or barium enema and routine hematological, biochemical,and thyroid function tests
Use of opioids within the previous 2 weeks
Severe cardiac or renal disease
Neurological diseases such as multiple sclerosis or stroke
Rectal prolapse or active anal fissures
Alternating pattern of constipation and diarrhea
Pregnant women or nursing mothers

Exclusion criteria for patients with fecal incontinence Severe diarrhea with BristolStool consistency ≥ Type 6 2. On opioids (except on stable doses > 3months) 3. Activedepression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure orsevere Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis

Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers

Exclusion criteria for patients with urinary incontinence

Continuous urine leakage
Active depression
Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD
Rectal prolapse or active anal fissure
Pregnant women or nursing mothers

Study Design

March 27, 2023

December 31, 2026

Study Description

Biofeedback therapy is an effective treatment for the management of patients with constipation and dyssynergic defecation, urinary incontinence, and fecal incontinence, problems that affect 25% of the population in USA. However, it is labor-intensive, costly, requires multiple office or hospital visits, is not widely available to the vast majority of patients in the community, and is not covered by many insurance companies. It is therefore imperative that a more pragmatic biofeedback treatment program that can be administered at home ought to be developed. Our previous studies have shown that home biofeedback training can be just as useful as office-based training, both for constipation with dyssynergia and fecal incontinence. These studies were however performed with older technology that included placement of anal probes connected to hand-held monitors with a liquid crystal display of flashing lights indicating changes in anal pressures. However, these methods are cumbersome and not user-friendly. Further, there is no commercially available home biofeedback system for dyssynergic defecation.

The advent of newer digital technology using cellphone app-based applications, with real time animations and pictorial displays of anorectal anatomical changes than the traditional liquid crystal display (LCD) lights and computer monitors, if adopted, could immensely improve our ability to provide biofeedback training. Also, the interactive images of the human anatomy that are both dynamic and change in real time during the biofeedback maneuvers can prove to be a significant advance over line tracings showing pressure or electromyogram (EMG) changes that many patients find it difficult to comprehend. These animated real time images could enable the patient to visualize and directly connect with their anal or rectal or pelvic floor muscle dysfunction that is causing their bowel or urinary problem. Also, the use of Bluetooth technology will enable wireless transmission of the pressure changes from inside the body to a cellphone display system, avoiding the hassles of connecting a probe with a hand-held device, to view changes. Further, the ability to provide voice guided instructions using the cellphone application (APP) will provide a structured treatment program on how to perform biofeedback training at home that mirrors the office biofeedback training. A 3 sensor electronic anorectal probe with a balloon will be placed in the rectum for assessment of anal and rectal pressures, and this will communicate wirelessly with the cellphone app. This new home biofeedback system could significantly improve our current method of performing biofeedback training.

Our specific aims are: 1) To test the feasibility, efficacy and safety of a wireless anorectal probe, and a cellphone app-based and Bluetooth interfaced, voice guided home biofeedback training system. 2) To compare the efficacy and safety of home biofeedback therapy with the standard of care office biofeedback therapy for the treatment of patients with dyssynergic constipation, fecal incontinence, and urinary incontinence; 3) To examine and compare the cost-effectiveness of home biofeedback therapy with office biofeedback therapy, in each of the 3 patient cohorts.

Our overall hypothesis is that Home Biofeedback Therapy (HBT) is non-inferior to Office-Biofeedback Therapy (OBT), but is more user friendly, easy to administer, and cost effective for the management of patients with constipation and dyssynergic defecation, fecal incontinence and urinary incontinence.

Connect with a study center

Augusta University
Augusta, Georgia 30912
United States
Active - Recruiting

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