Health TrialsbyHealthPanel

Fecobionics in Biofeedback Therapy in Dyssynergia Patients

ConditionsDyssynergiaConstipation
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Fecobionics

    Device

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: FecobionicsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Expulsion Duration

The time it takes to defecate Fecobionics

Time frame
1.5 year
2

Pressure Difference between front and rear ends of Fecobionics

A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases.

Time frame
1.5 year

Secondary outcomes

1

Anorectal angle

Anorectal angle is an important parameter for defecation

Time frame
1.5 year
2

Mechanical Tension of Fecobionics

To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure.

Time frame
1.5 year
3

Expulsion Velocity

Measured from the time difference between multiple sensor data

Time frame
1.5 year
4

Cross-sectional area

Computed by diameter

Time frame
1.5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The California Medical Innovations Institute, Inc.

Lead sponsor

Scripps Clinic

Collaborator

Augusta University Medical Center

Collaborator

Source ClinicalTrials.gov
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