Defecation Patterns in Constipated Patients

• Status: Not yet recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: All

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 shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction/peristalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex/process in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Bisacodyl

Criteria

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.

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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.