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Clinical Trial NCT04903470 for Constipation by Outlet Obstruction is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Defecation Patterns in Constipated Patients 130 Novel Treatment

Recruiting
Clinical Trial NCT04903470 is an interventional study for Constipation by Outlet Obstruction that is recruiting. It started on December 19, 2022 with plans to enroll 130 participants. Led by The California Medical Innovations Institute, Inc., it is expected to complete by December 30, 2026. The latest data from ClinicalTrials.gov was last updated on October 21, 2025.
Brief Summary
Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and sha...Show More
Detailed Description
For aim 1 study, the hypothesis is that a correctly performed Valsalva maneuver in the presence of an inflated bag (stool) in the rectum initiates the rectal peristaltic reflex that results in contraction of the rectal smooth muscles cranial to the bag and relaxation of the rectum and internal anal sphincter caudal to the bag. The Fecobionics device records rectal pressure as a surrogate of abdominal wall contraction...Show More
Official Title

Understanding Defecation Patterns Using a Novel Device (Fecobionics) to Improve Treatment of Constipation

Conditions
Constipation by Outlet Obstruction
Other Study IDs
  • CALM-CLIN-2025-edited
NCT ID Number
NCT04903470
Start Date (Actual)
2022-12-19
Last Update Posted
2025-10-21
Completion Date (Estimated)
2026-12-30
Enrollment (Estimated)
130
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Obstructed defecation
Pelvic floor dysynergia
Paradoxical contraction of the anal sphincter
Anorectal motility
Impedance planimetry of anal sphincter
Primary Purpose
Basic Science
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEffect of atropine on the defecation
Atropine is an anticholinergic drug and expected to inhibit rectal contractions and inhibit evacuation of the rectal balloon. Each subject will be studied twice once with and once without atropine.
Atropin
Atropin is an anticholinergic drug that is expected to inhibit rectal contractions and make defecation more difficult.
ExperimentalEffect of bisacodyl on the defecation
Bisacodyl is a stimulant of rectal contraction and expected to facilitate evacuation of rectal balloon (fecobionics device). Each subject will be studied twice, once with and once without bisacodyl.
Bisacodyl
Biscodyl a stimulant laxative is expected to stimulate rectal contraction and enhance expulsion of Fecobionics
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Evacuation duration of rectal balloon.
Evacuation duration is the time it takes from evacuation is initiated until the balloon is expelled. Change from the evacuation duration baseline induced by atropine and bisacodyl.
3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rectal contraction pressure.
Rectal contractions, i.e. increase in pressure, will be induced by balloon distension. Change in the rectal pressure baseline induced by Atropine and bisacodyl.
3 years
Anorectal angle.
The anorectal angle is the angle between the direction of the anal canal and rectum. Change in baseline anorectal angle induced by atropine and bisacodyl.
4 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

Two groups of subjects will be studied - normal healthy subjects and patients with chronic constipation.

Normal subjects:

Inclusion criteria *Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.

  • Subjects not willing to consent and undergo the specified tests in this study
  • Pregnant women
  • Subjects with concurrent fecal incontinence and constipation symptoms
  • Chronic diseases
  • Taking medications that affect anorectal function
  • History of anorectal surgery or bowel resection.

Constipation patients:

Inclusion Criteria:

  • Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months:

    1. Fewer than three spontaneous bowel movements per week,

    2. Straining for more than 25% of defecation attempts,

    3. Lumpy or hard stools for at least 25% of defecation attempts, and

    4. sensation of anorectal obstruction or blockage.

      -

      Exclusion Criteria:

  • Patients not willing to consent and undergo the specified tests in this study

  • pregnant women and patients with concurrent fecal incontinence

  • History of anorectal surgery or bowel resection.

The California Medical Innovations Institute, Inc. logoThe California Medical Innovations Institute, Inc.
Study Responsible Party
Hans Gregersen, PhD, Principal Investigator, Professor of Medicine, The California Medical Innovations Institute, Inc.
Study Central Contact
Contact: Hans Gregersen,, PhD, 858-249-7400, [email protected]
Contact: Satish Rao, MD, PhD, 7067212238, [email protected]
2 Study Locations in 1 Countries

California

California Medical Innovations Institute, San Diego, California, 92121, United States
Active, not recruiting

Georgia

Augusta University Medical Center, Augusta, Georgia, 30912, United States
Satish Rao, MD, PhD, Contact, 7067212238, [email protected]
Recruiting