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Home Biofeedback Therapy for Bowel and Urinary Incontinence (Bioanatoner Trial)

N/A

Recruiting

Led By Satish Rao, MD, PhD

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with constipation and dyssynergic defecation must meet Rome IV criteria for functional constipation with specific symptoms

Patients with constipation and dyssynergic defecation must demonstrate a dyssynergic pattern of defecation during repeated attempts, as well as specific criteria on anorectal manometry

Must not have

Patients with fecal incontinence must not have severe diarrhea, be on opioids, have active depression, specific comorbid illnesses, ulcerative and Crohn's colitis, rectal prolapse, active anal fissure, or be pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks & 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a home biofeedback system to help people with constipation, urinary leakage, or stool leakage. It will compare it to standard care and look at its safety and cost-effectiveness.

Who is the study for?

This trial is for individuals with bowel or urinary incontinence, or bedwetting. Participants must have had symptoms for several months and meet specific diary criteria. Those with constipation need to fit the Rome IV criteria and show a certain pattern on tests. People can't join if they have related structural diseases, severe health conditions, are using opioids recently, or are pregnant/nursing.

What is being tested?

The study is testing home biofeedback therapy using wireless devices and apps against office-based therapy to treat defecation issues and incontinence. It aims to see which method is more effective, safer, and cost-efficient by comparing patient outcomes from both treatments.

What are the potential side effects?

While not explicitly stated here, biofeedback therapy generally has minimal side effects but may include discomfort during use of the equipment or minor psychological stress due to self-monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet the specific criteria for functional constipation.

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I have constipation due to muscle coordination issues, confirmed by a special test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fecal incontinence but do not have severe diarrhea, depression, certain illnesses, rectal issues, or am not pregnant/nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks & 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks & 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks & 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

Amplitudes (Millivolts of the nerve) for lumbo-rectal Motor Evoked Potential (MEP) for patients within all 3 groups

Amplitudes (Millivolts of the nerve) for sacro-rectal Motor Evoked Potential (MEP) for patients within all 3 groups

Anal Sphincter Function-Anal Resting Pressure for patients within all 3 groups

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home Biofeedback Therapy (HBT)Experimental Treatment1 Intervention

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 II: Office Biofeedback Therapy (OBT)Active Control1 Intervention

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.

0 / 3Eligibility criteria met