RECRUITING

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

Conditions

Fecal Incontinence Dyssynergic Defecation Urinary Incontinence home biofeedback therapy office biofeedback therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-27

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05771597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Inclusion Criteria for patients with constipation and dyssynergic defecation 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 for patients with constipation and dyssynergic defecation 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 * Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \> 3months) 3. Active depression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis 6. Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers * Exclusion criteria for patients with urinary incontinence 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

Inclusion Criteria

Exclusion Criteria

* Inclusion Criteria for patients with constipation and dyssynergic defecation
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 for patients with constipation and dyssynergic defecation
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
* Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \> 3months) 3. Active depression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis 6. Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers
* Exclusion criteria for patients with urinary incontinence
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

Contacts and Locations

Study Contact

Satish Rao, MD, PhD

CONTACT

706-721-2239

srao@augusta.edu

Bianca Marsh, BS

CONTACT

706-446-5765

bmarsh@augusta.edu

Principal Investigator

Satish Rao, MD, PhD

PRINCIPAL_INVESTIGATOR

Augusta University

Study Locations (Sites)

Augusta University

Augusta, Georgia, 30912

United States

Collaborators and Investigators

Sponsor: Augusta University

Satish Rao, MD, PhD, PRINCIPAL_INVESTIGATOR, Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-27

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-03-27

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Fecal Incontinence
Dyssynergic Defecation
Urinary Incontinence