Defecatory disorders such as chronic constipation (CC) and fecal incontinence (FI) affect 25% of the population and the incidence is rising. These disorders pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial. CC, a symptom of underlying defecatory disease, affects 12-19% of Americans with expenditure on laxatives being nearly $1B yearly. Another defecatory disorder is FI, which affects 10% of the population and its incidence is rising. Approximately 15% of the population in USA over 70 years of age as well as 10% of those under 70 suffer from FI. It is an under-diagnosed problem due to patients often being too embarrassed to seek medical help. The mechanisms of defecation and continence depend on colorectal motility, stool consistency, rectal capacity and compliance, anorectal sensitivity, and coordination of the pelvic floor muscles and sphincter. Management options for these patients are limited due to the multifactorial control of defecation and continence; and the difficulties in identifying the exact cause of CC and FI with current diagnostics. Precise diagnosis is necessary to judge if the patient is eligible for biofeedback treatment. 3DTs multimodal Fecobionics device is a novel, anorectal natural orifice insertable device that provides high resolution pressures, orientation, bending, and shape during defecation of the device. It simulates feces and electronically measures relevant parameters of defecation such as the propulsive force, anal sphincter relaxation, and anorectal angle. Results from previous studies have shown safe and distinctive recordings of important anorectal function parameters. Specifically, the device did not cause tissue injury to rectum or the anal canal as verified by visual inspection of mucosa and histological examination. Fecobionics evacuations in non- GLP pig studies showed characteristic pressure profiles and orientation/bending data obtained with wired as well as wireless transmission. Furthermore, simultaneous data from human studies outside of the US have provided the first-in-man studies with the initial wired prototypes of Fecobionics. The human studies have confirmed that the device is safe and easy-to-use in the clinical setting with integration of most current tests in one, and high degree of agreement with key parameters obtained with the balloon expulsion test and defecography. Distinct differences were found, however, when compared to the manometry gold standard as there are also difference between current clinical tests. To advance these outstanding findings and to move closer to commercialization of Fecobionics, this Fast track proposal intends to accomplish the following: Phase I Aim 1: Modification of filling tube detachment. We will develop an optimized, easy-to-operate tube with needed retention force and detachment. Phase II Specific Aims: 1) GLP studies in swine to demonstrate safety, 2) In vivo comparison of anorectal angle and pressure measurements, and 3) 510(k) submission. To obtain data for submission of 510(k) for market release of wireless technology. The long-term goal is to develop the technology for biofeedback training by patients in their homes with remote assistance by practitioners to substantially reduce healthcare costs. Public Health Relevance Statement NARRATIVE Up to 25% of the adult population suffer from anorectal symptoms that are difficult to diagnose, classify and determine the cause of dysfunction. The purpose of this Fast Track proposal is to submit a 510(k) application to obtain regulatory approval for electronic feces device that enables high-tech bionics measurements during defecation.
Project Terms: Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Aging ; sphincter ani muscle structure ; Anal Sphincter ; Animals ; Award ; Bionics ; cell motility ; Cell Locomotion ; Cell Migration ; Cell Movement ; Cellular Migration ; Cellular Motility ; Motility ; Clinical Research ; Clinical Study ; Constipation ; Data Analyses ; Data Analysis ; data interpretation ; Defecation ; bowel movement ; Diagnosis ; Diet ; diets ; Disease ; Disorder ; Expenditure ; Fecal Incontinence ; Anal Incontinence ; Bowel incontinence ; Feces ; stool ; Goals ; Gold ; Hand ; Homeostasis ; Autoregulation ; Physiological Homeostasis ; Human ; Modern Man ; Incidence ; Manometry ; Manometry Biochemistry ; Marketing ; Methods ; Mucous Membrane ; Mucosa ; Mucosal Tissue ; Patient Education ; Patient Instruction ; Patient Training ; Patients ; pressure ; Rectum ; Relaxation ; Risk ; Safety ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Testing ; Time ; Measures ; Health Care Costs ; Health Costs ; Healthcare Costs ; Healthcare ; health care ; Tube ; rectal ; Chronic ; Clinical ; Phase ; Histologic ; Histologically ; Physiological ; Physiologic ; Medical ; Evaluation ; Anal canal ; Visual ; Measurement ; Functional disorder ; Dysfunction ; Physiopathology ; pathophysiology ; laxative ; Laxative Preparation ; Therapeutic ; Shapes ; Diagnostic ; mechanical ; Mechanics ; Pattern ; System ; Defecography ; Colon or Rectum ; colo-rectal ; colorectum ; Colorectal ; American ; human data ; novel ; Agreement ; anorectal disorder ; Modality ; Devices ; Pelvic Floor Muscle ; Sphincter ; Symptoms ; Age-Years ; Data ; Resolution ; in vivo ; Wireless Technology ; wireless ; transmission process ; Transmission ; Characteristics ; Process ; Modification ; point of care ; care burden ; design ; designing ; Population ; clinically relevant ; clinical relevance ; user-friendly ; prototype ; commercialization ; multimodality ; multi-modality ; verification and validation ; Biofeedback Training ; Biofeedback Approach ; Biofeedback Therapy ; Biofeedback Treatment ; first-in-human ; first in man ; data submission ; data deposition ; tissue injury ; injury to tissue ; Home ;
