Clinical trial NCT05807321: Fecobionics in Biofeedback Therapy in Dyssynergia Patients
Official title: Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyssynergia
Constipation
Keywords: Fecobionics
Biofeedback therapy
Defecation
Lead sponsor: The California Medical Innovations Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Scripps Clinic
First posted: 2023-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.

Detailed description: This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.

Eligibility criteria: Inclusion Criteria:

1. Subject must provide written informed consent.
2. Age between 21-75 years.
3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.

Exclusion Criteria:

1. Female who is pregnant or lactating.
2. Prior abdominal or anorectal surgery or bowel resection.
3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
4. Confirmed or suspected COVID-19 infection.
5. Severe cardiovascular disease.
6. Subjects not willing to consent and undergo the specified tests in this study.
7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Primary outcomes:
measure: Expulsion Duration
timeFrame: 1.5 year
measure: Pressure Difference between front and rear ends of Fecobionics
timeFrame: 1.5 year
Secondary outcomes:
measure: Anorectal angle
timeFrame: 1.5 year
measure: Mechanical Tension of Fecobionics
timeFrame: 1.5 year
measure: Expulsion Velocity
timeFrame: 1.5 year
measure: Cross-sectional area
timeFrame: 1.5 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: California Medical Innovations Institute
state: California
Study officials:
References: