Clinical trial NCT05771597: Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
Official title: Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Incontinence
Dyssynergic Defecation
Urinary Incontinence
Keywords: home biofeedback therapy
office biofeedback therapy
fecal incontinence
dyssynergic defecation
urinary incontinence
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion 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.

Inclusion Criteria for patients with fecal incontinence

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

Inclusion Criteria for patients with urinary incontinence

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:

* 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

Primary outcomes:
measure: The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
timeFrame: 6 weeks (short term)
measure: The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
timeFrame: 12 weeks (long term)
measure: the number of fecal incontinence (FI) episodes for the FI group
timeFrame: 6 weeks (short term)
measure: the number of fecal incontinence (FI) episodes for the FI group
timeFrame: 12 weeks (long term)
measure: the number of Urinary Incontinence (UI) episodes for UI group
timeFrame: 6 weeks (short term)
measure: the number of Urinary Incontinence (UI) episodes for UI group
timeFrame: 12 weeks (long term)
Secondary outcomes:
measure: stool frequency for the patients with dyssynergic defecation and fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: stool consistence for the patients with dyssynergic defecation and fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: Number of spontaneous bowel movements (SBM) for patients with dyssynergic defecation
timeFrame: 6 weeks & 12 weeks
measure: straining effort (1-3 scale) for patients with dyssynergic defecation
timeFrame: 6 weeks & 12 weeks
measure: Proportion of patients who used digital maneuver with stooling for patients with dyssynergic defecation
timeFrame: 6 weeks & 12 weeks
measure: Patient Assessment of Constipation Symptoms (PAC-SYM) for patients with dyssynergic defecation
timeFrame: 6 weeks & 12 weeks
measure: Patient Assessment of Constipation - Quality of Life (PAC-QoL) for patients with dyssynergic defecation
timeFrame: 6 weeks & 12 weeks
measure: International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) for patients with urinary incontinence
timeFrame: 6 weeks & 12 weeks
measure: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) for patients with urinary incontinence
timeFrame: 6 weeks & 12 weeks
measure: International Consultation on Incontinence Questionnaire-Bowels (ICIQ-B) for patients with fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: Fecal Incontinence Severity Sore (FISS) for patients with fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: Fecal Incontinence Severity Index (FISI) for patients with fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: Fecal Incontinence Quality OF Life Scale (FIQOL) for patients with fecal incontinence
timeFrame: 6 weeks & 12 weeks
measure: Anal Sphincter Function-Sustained Squeeze Pressure for patients within all 3 groups
timeFrame: 6 weeks
measure: Anal Sphincter Function-Anal Resting Pressure for patients within all 3 groups
timeFrame: 6 weeks
measure: Anal Sphincter Function-Squeeze Pressure for patients within all 3 groups
timeFrame: 6 weeks
measure: Rectal Sensation-First Sensation (volume of air) for patients within all 3 groups
timeFrame: 6 weeks
measure: Rectal Sensation- Desire to defecate for patients within all 3 groups
timeFrame: 6 weeks
measure: Rectal Sensation-Urgency to Defecate for patients within all 3 groups
timeFrame: 6 weeks
measure: Rectal Sensation-Maximum tolerable volume for patients within all 3 groups
timeFrame: 6 weeks
measure: Rectal Compliance for patients within all 3 groups
timeFrame: 6 weeks
measure: Amplitudes (Millivolts of the nerve) for lumbo-rectal Motor Evoked Potential (MEP) for patients within all 3 groups
timeFrame: 6 weeks
measure: Amplitudes (Millivolts of the nerve) for sacro-rectal Motor Evoked Potential (MEP) for patients within all 3 groups
timeFrame: 6 weeks
measure: MEP Index The area under the curve of the Motor Evoked Potential (MEP) response for patients within all 3 groups
timeFrame: 6 weeks
measure: Psychological Function Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety Questionnaire for patients within all 3 groups
timeFrame: 6 weeks
measure: Psychological Function PROMIS Depression Questionnaire for patients within all 3 groups
timeFrame: 6 weeks
measure: Psychological Function PROMIS Efficacy Questionnaire for patients within all 3 groups
timeFrame: 6 weeks
measure: Global Assessment of bowel satisfaction for patients with fecal incontinence and dyssynergic defecation
timeFrame: 6 weeks and 12 weeks
measure: Global Assessment of bowel satisfaction-Visual Analog Scale for patients with fecal incontinence and dyssynergic defecation
timeFrame: 6 weeks and 12 weeks
measure: Global Assessment of urinary symptoms for patients with urinary incontinence
timeFrame: 6 weeks and 12 weeks
measure: Global Assessment-Visual Analog Scale of urinary symptoms for patients with urinary incontinence
timeFrame: 6 weeks and 12 weeks
measure: Cost effectiveness analysis for patients within all 3 groups
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Satish Rao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: