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

NCT05771597 | Recruiting

• 1 other identifier: 1739484
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Fecal Incontinence; Dyssynergic Defecation; Urinary Incontinence

Keywords

home biofeedback therapy; office biofeedback therapy; fecal incontinence; dyssynergic defecation; urinary incontinence

Outcome Measures

Primary Outcomes (6)

• The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation

  A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern

  6 weeks (short term)

• The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation

  A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern

  12 weeks (long term)

• the number of fecal incontinence (FI) episodes for the FI group

  A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes

  6 weeks (short term)

• the number of fecal incontinence (FI) episodes for the FI group

  A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes

  12 weeks (long term)

• the number of Urinary Incontinence (UI) episodes for UI group

  A responder for UI is defined as an individual reporting at least 50% reduction in weekly number of UI episodes

  6 weeks (short term)

• the number of Urinary Incontinence (UI) episodes for UI group

  A responder for UI is defined as an individual reporting at least 50% reduction in weekly number of UI episodes

  12 weeks (long term)

Secondary Outcomes (32)

• stool frequency for the patients with dyssynergic defecation and fecal incontinence

  6 weeks & 12 weeks

• stool consistence for the patients with dyssynergic defecation and fecal incontinence

  6 weeks & 12 weeks

• Number of spontaneous bowel movements (SBM) for patients with dyssynergic defecation

  6 weeks & 12 weeks

• straining effort (1-3 scale) for patients with dyssynergic defecation

  6 weeks & 12 weeks

• Proportion of patients who used digital maneuver with stooling for patients with dyssynergic defecation

  6 weeks & 12 weeks

Study Arms (2)

Home Biofeedback Therapy (HBT)

EXPERIMENTAL

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.

Other: Home Biofeedback therapy

Office Biofeedback Therapy (OBT)

ACTIVE COMPARATOR

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.

Other: Office biofeedback therapy

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.

Home Biofeedback Therapy (HBT)

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.

Office Biofeedback Therapy (OBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• Minimum age of 18 years
• Recurrent episodes of fecal incontinence for six months
• No colonic mucosal disease

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence; Urinary Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Satish Rao, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish Rao, MD, PhD

CONTACT

706-721-2239; srao@augusta.edu

Bianca Marsh, BS

CONTACT

706-446-5765; bmarsh@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This is a new home biofeedback device feasibility study that will be tested in 3 groups of patients; 1. Fecal incontinence (24 subjects); 2. Dyssynergic constipation (24 subjects); 3. Urinary incontinence (24 subjects). The investigators anticipate enrolling 20 in each group and an expected 20% dropout.

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 16, 2023
• Study Start: March 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (1)