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

NCT ID: NCT05771597

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Fecal Incontinence; Dyssynergic Defecation; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Home Biofeedback therapy

Intervention Type: 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 (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.

Group Type: ACTIVE_COMPARATOR

Office biofeedback therapy

Intervention Type: 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.

Interventions

Home 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.

Intervention Type: OTHER

Office 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Minimum age of 18 years

2. 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 dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.

• Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria:
• Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute.
• Prolonged colonic transit time on wireless motility capsule (>59 hours) or >5 markers retained on a colonic transit study.
• Inability to evacuate or ≥ 50% retention of barium during defecography.

1. Minimum age of 18 years

2. Recurrent episodes of fecal incontinence for six months

3. No colonic mucosal disease

4. On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week

1. Minimum age of 18 years

2. Recurrent episodes of urinary incontinence for three months

3. Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary

Exclusion Criteria

1. Evidence of structural or metabolic disease that could cause constipation, as assessed by colonoscopy or barium enema and routine hematological, biochemical, and thyroid function tests

2. Use of opioids within the previous 2 weeks

3. Severe cardiac or renal disease

4. Neurological diseases such as multiple sclerosis or stroke

5. Rectal prolapse or active anal fissures

6. Alternating pattern of constipation and diarrhea

7. Pregnant women or nursing mothers

1. Continuous urine leakage

2. Active depression

3. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD

4. Rectal prolapse or active anal fissure

5. Pregnant women or nursing mothers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Satish Rao

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Satish Rao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Satish Rao, MD, PhD

Role: CONTACT

srao@augusta.edu

706-721-2239

Bianca Marsh, BS

Role: CONTACT

bmarsh@augusta.edu

706-446-5765

Facility Contacts

Satish Rao, MD, PhD

Role: primary

srao@augusta.edu

706-721-2239

Bianca Marsh, BS

Role: backup

bmarsh@augusta.edu

706-446-5765

Other Identifiers

1739484

Identifier Type: -

Identifier Source: org_study_id