Fecobionics Device for Chronic Constipation

Recruiting in Palo Alto (17 mi)

Overseen by Hans Gregersen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Approved in 2 Jurisdictions

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{2 3 6 9 10}

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

I have chronic constipation based on specific symptoms I've had for the last 3 months.

I have regular bowel movements without difficulty.

Exclusion Criteria

I am not pregnant, willing to undergo specific tests, and have no history of bowel surgery.

Normal subjects: 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.

Treatment Details

Interventions

• Fecobionics (Procedure)

Trial Overview The study is testing how well a new device called Fecobionics can mimic and measure the natural process of defecation by recording various parameters in both healthy subjects and patients with chronic constipation. It aims to improve understanding of normal and abnormal defecatory patterns without using invasive methods or radiation.

Participant Groups

Group I: Effect of bisacodyl on the defecation Experimental Treatment 1 Intervention

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.

Group II: Effect of atropine on the defecation Experimental Treatment 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California San Diego La Jolla, CA

Who Is Running the Clinical Trial?

University of California, San Diego Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Anorectal biofeedback: an effective therapy, but can we shorten the course to improve access to treatment? [2023] Instrumented anorectal biofeedback (BF) improves symptoms and quality of life in patients with faecal incontinence and defecation disorder-associated chronic constipation. However, demand for BF greatly outweighs availability, so refinement of the BF protocol, in terms of the time and resources required, is of importance. Our aim was to evaluate the outcomes of an abbreviated BF protocol in patients with defecation disorder-associated chronic constipation and/or faecal incontinence compared to standard BF.

2. England pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. [2019] Fifteen subjects presenting with intractable constipation due to obstructive defecation, mean (SEM) duration 8.8 (1.8) years, had the inappropriate contraction and electromyographic changes in the pelvic floor muscles and external and sphincter typical of this condition. An electromyographically derived index was used to grade its severity. A self applied biofeedback device was used to allow electromyographic recording of the abnormal external anal sphincter. The subjects were encouraged to reduce the abnormal electromyographic activity on straining after instruction and training. The procedure was intended as a relearning process in which the non-relaxing activity of the pelvic floor was gradually suppressed. Biofeedback training was maintained on a domiciliary basis for a mean time of 3.1 weeks and resulted in a significant reduction in the anismus index (mean (SEM) 69.9 (7.8)% before biofeedback, mean 14 (3.9)% after biofeedback, p less than 0.01). There was an associated reduction in the time spent straining at stool and in the difficulty of defecation and an increased frequency of defecation. Defecatory video proctograms in six subjects showed improvements in the anorectal angle during straining and evacuation. The clinical benefit to the patients persisted after a mean follow up of 6.2 months.

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of Biofeedback Therapy in Clinical Practice for the Management of Chronic Constipation and Fecal Incontinence. [2023] Chronic constipation (CC) and fecal incontinence (FI) are often secondary to pelvic floor neuromuscular sensory or motor dysfunction. Biofeedback therapy (BFT) uses visual and verbal feedback to improve anorectal coordination, strength and sensation. In clinical trials, BFT demonstrated response rates between 70% and 80%. The purpose of this study is to determine the effectiveness of BFT in clinical practice.

4. China pubmed.ncbi.nlm.nih.gov

[Predictors of efficacy of biofeedback therapy in patients with chronic constipation]. [2014] To explore the anorectal physiology, psychological state, quality of life, lifestyle of patients with chronic constipation (CC) and evaluate the factors which potentially predict the efficacy of biofeedback therapy (BF).

5. United States pubmed.ncbi.nlm.nih.gov

Biofeedback is effective therapy for fecal incontinence and constipation. [2022] To define the role of biofeedback in fecal incontinence and constipation.

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Technique of functional and motility test: how to perform biofeedback for constipation and fecal incontinence. [2021] Biofeedback therapy is an instrument-based learning process centered on operant conditioning. The goal of biofeedback therapy in defecatory disorders is to strengthen the pelvic floor muscles, retrain rectal sensation and coordinate pelvic floor muscles during evacuation. Biofeedback therapy, in a broader sense, includes education, counseling, and diaphragmatic muscle training as well as exercise, sensory, and coordination training. For dyssynergic defecation, biofeedback therapy is a well-known and useful treatment option that had response rates of approximately 70-80% in randomized controlled trials. Biofeedback therapy for dyssynergic defecation consists of improving the abdominal push effort together with biofeedback technique-guided pelvic floor relaxation followed by simulated defecation and/or sensory training. For fecal incontinence, the results of a randomized controlled trial, which had a response rate of 76%, indicated that biofeedback therapy is useful in selected patients who fail to respond to conservative treatment and that training to enhance rectal discrimination of sensation may be helpful in reducing fecal incontinence. The focus of biofeedback therapy for fecal incontinence is on exercising external sphincter contractions under instant feedback, either alone or synchronously with rectal distension and/or sensory training. Biofeedback therapy is a safe treatment that may produce durable improvement beyond the active treatment period; however, a well-designed study to establish a standard protocol for biofeedback therapy is needed. This review discusses the technique of biofeedback therapy to achieve the goal and clinical outcomes for constipation and fecal incontinence.

7. United States pubmed.ncbi.nlm.nih.gov

Biofeedback treatment of gastrointestinal disorders. [2019] Biofeedback has had a greater impact on gastroenterology than on any other medical subspecialty. Biofeedback is the treatment of choice for many of the most common types of fecal incontinence, and preliminary studies suggest that it is likely to become a preferred method for treating patients with constipation related to inability to relax the striated pelvic floor muscles during defecation. This dysfunction may account for up to 50% of patients with chronic constipation. Thermal biofeedback forms part of a multicomponent behavioral treatment for irritable bowel syndrome that is reported to be effective, and other promising applications of biofeedback for gastrointestinal disorders are under investigation.

8. United States pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. [2015] Biofeedback is a scarce, resource-intensive clinical therapy. It is used to treat patients with bowel problems, including fecal incontinence (FI), who fail to respond to simple dietary advice, medication, or pelvic floor exercises. Populations are aging and younger cohorts use technology in managing their health, affording FI self-management opportunities.

9. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018] Pelvic floor biofeedback therapy is safe and effective in chronic constipation, urinary incontinence, fecal incontinence and pelvic floor pain whereas the heterogeneous indication affects the efficacy evaluation and technical communication. The best indications are as follows: (1) Pelvic floor myogenic dysfunction without severe pelvic organ prolapse and severe neurogenic defect; (2) Patients have good mental cognition and treatment adherence who fulfill the training with the therapist. The training protocol is conducted at hospital or at home, and is as follows: (1) To help patients to target the pelvic floor muscles; (2) To improve the type I( muscle tonic contraction variability; (3) To improve the pelvic floor type I( and type II( muscles activity coordination; (4) To enhance the pelvic floor muscle strength and rectum defecation awareness. The biofeedback efficacy is evaluated with different symptoms, questionnaire score, patient satisfaction recognition and long-term outcomes. Pelvic floor biofeedback therapy will be highlighted and extended to the primary care in near future following the pragmatic randomized controlled clinical trials, collection and analysis of big data.

10. Germany pubmed.ncbi.nlm.nih.gov

Patient-Controlled Biofeedback Device for the Treatment of Fecal Incontinence: A Pilot Study. [2018] Although biofeedback has been used as a first-line therapy for fecal incontinence, it is known to be time consuming and demands attendance to a hospital during the whole period of treatment. In this study, we describe a new biofeedback device specifically developed for home treatment of fecal incontinence, which consists of a microprocessor controlled unit able to register and store the anal pressure waves corresponding to exercises performed by patients at home. In order to test the new device, a pilot study including ten patients with fecal incontinence was conducted. Evaluation of patients before and after the biofeedback training showed significant improvement in manometric and clinical parameters of anal continence. The new method may improve compliance of patients with the training program and reduce their need to be supervised during the treatment. It might represent a new alternative for the treatment of fecal incontinence.