Fecobionics in Biofeedback Therapy in Dyssynergia Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorThe California Medical Innovations Institute, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fecobionics
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
The California Medical Innovations Institute, Inc.
Lead sponsor
Scripps Clinic
Collaborator
Augusta University Medical Center
Collaborator
Source ClinicalTrials.gov