Measuring defecation mechanics in people with outlet obstruction constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses an electronic simulated stool (Fecobionics) that records pressures, cross-sectional area, orientation, bending, and shape as it is expelled to mimic natural defecation. Investigators will combine Fecobionics with abdominal wall and external anal sphincter EMG and high-frequency rectal ultrasound to separate contributions from abdominal and rectal muscle activity. Separate experiments include pharmacologic manipulation with atropine to block rectal smooth muscle and use of bisacodyl as needed for expulsion challenges, enrolling healthy volunteers and patients meeting Rome IV criteria for obstructed defecation. Data will compare spatiotemporal patterns of pressure and muscle activity between groups to define rectal peristalsis and the defecatory reflex.

Why it matters

Who can join: the full rules

Inclusion Criteria: 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.

Exclusion Criteria:

* 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.

Where it's running

• Augusta University Medical Center
  Augusta, Georgia, United States Recruiting
• California Medical Innovations Institute
  San Diego, California, United States Active not recruiting

Study contacts

• Principal investigator: Hans Gregersen, MD, PhD — California Medical Innovations Institute
• Study coordinator: Hans Gregersen,, PhD
• Email: hag@giome.org
• Phone: 858-249-7400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.