Fecobionics in Biofeedback Therapy in Dyssynergia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecobionics.
- Who it may be relevant to
- Registry conditions: Dyssynergia, Constipation. Basic parameters: 21 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
Overview
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.
Interventions
- Device Fecobionics
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.
Primary outcome measures
- Expulsion Duration [Time frame: 1.5 year]
- Pressure Difference between front and rear ends of Fecobionics [Time frame: 1.5 year]
Secondary outcome measures (4)
- Anorectal angle [Time frame: 1.5 year]
- Mechanical Tension of Fecobionics [Time frame: 1.5 year]
- Expulsion Velocity [Time frame: 1.5 year]
- Cross-sectional area [Time frame: 1.5 year]
Eligibility criteria
Inclusion criteria
- Subject must provide written informed consent.
- Age between 21-75 years.
- Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
Exclusion criteria
- Female who is pregnant or lactating.
- Prior abdominal or anorectal surgery or bowel resection.
- Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
- Confirmed or suspected COVID-19 infection.
- Severe cardiovascular disease.
- Subjects not willing to consent and undergo the specified tests in this study.
- Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- California Medical Innovations Institute — San Diego
- Digestive Health Center- Augusta University — Augusta
Identifiers
NCT: NCT05807321 · CALM-CLIN-2023 BFT