RECRUITING

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

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

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.

Official Title

Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Quick Facts

Study Start:2023-08-15
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05807321

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:21 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject must provide written informed consent.
  2. 2. Age between 21-75 years.
  3. 3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
  1. 1. Female who is pregnant or lactating.
  2. 2. Prior abdominal or anorectal surgery or bowel resection.
  3. 3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
  4. 4. Confirmed or suspected COVID-19 infection.
  5. 5. Severe cardiovascular disease.
  6. 6. Subjects not willing to consent and undergo the specified tests in this study.
  7. 7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Contacts and Locations

Study Locations (Sites)

California Medical Innovations Institute
San Diego, California, 92121
United States

Collaborators and Investigators

Sponsor: The California Medical Innovations Institute, Inc.

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 Date2023-08-15
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Fecobionics
  • Biofeedback therapy
  • Defecation

Additional Relevant MeSH Terms

  • Dyssynergia
  • Constipation