Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
Yes, if you are taking medications that affect anorectal function, you cannot participate in the trial.
What data supports the idea that Fecobionics Device for Chronic Constipation is an effective treatment?
The available research shows that biofeedback therapy, which is similar to the Fecobionics Device, has high success rates for treating chronic constipation. In clinical trials, biofeedback therapy helped 70% to 80% of patients improve their symptoms. Another study found that using a biofeedback device led to significant improvements in bowel movement frequency and ease, with benefits lasting for over six months. This suggests that the Fecobionics Device could be an effective treatment for chronic constipation.12345
What safety data exists for the Fecobionics treatment for chronic constipation?
Biofeedback therapy, which is related to the Fecobionics treatment, is considered a safe treatment for defecatory disorders such as chronic constipation and fecal incontinence. It has been shown to produce durable improvements beyond the active treatment period. However, a well-designed study to establish a standard protocol for biofeedback therapy is needed. The therapy has been effective in improving symptoms and quality of life, with response rates of approximately 70-80% in randomized controlled trials for dyssynergic defecation and 76% for fecal incontinence. The treatment is generally safe and involves strengthening pelvic floor muscles and retraining rectal sensation.12678
Is the Fecobionics Device a promising treatment for chronic constipation?
Yes, the Fecobionics Device is a promising treatment for chronic constipation. It uses biofeedback therapy, which has shown high success rates in improving bowel movements by helping patients retrain their pelvic floor muscles. This approach has been effective in increasing the frequency of bowel movements and reducing the difficulty of defecation.236910
Research Team
Hans Gregersen, MD
Principal Investigator
California Medical Innovations Institute
Eligibility Criteria
This trial is for adults with normal bowel movements or those meeting the Rome IV criteria for chronic constipation, which includes symptoms like infrequent bowel movements and difficulty during defecation. Excluded are pregnant women, individuals unwilling to consent to tests, those with fecal incontinence, significant chronic diseases, medication affecting anorectal function, or a history of relevant surgeries.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Fecobionics (Procedure)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Dr. Christopher Longhurst
University of California, San Diego
Chief Medical Officer since 2021
MD and MS in Medical Informatics from UC Davis
Patty Maysent
University of California, San Diego
Chief Executive Officer since 2016
MBA from Stanford University