Project Grant R01DK134689

FECOBIONICS MONITORING AND PREDICTION OF BIOFEEDBACK THERAPY OUTCOME IN PATIENTS WITH OBSTRUCTED DEFECATION. - ABSTRACT DEFECATORY DISORDERS AFFECT 25% OF THE POPULATION AND THEY ARE POORLY RECOGNIZED AND TREATED. THE INCIDENCE OF DEFECATORY DISORDERS INCLUDING CHRONIC CONSTIPATION IS RISING AND IT POSES A MAJOR HEALTHCARE BURDEN. THE UNDERLYING MECHANISMS FOR THESE DISORDERS ARE OFTEN NOT WELL UNDERSTOOD. OBSTRUCTED DEFECATION (DYSSYNERGIA) HAS SEVERAL CAUSES AND IS SUBDIVIDED IN FOUR SUBTYPES. DESPITE THE HIGH PREVALENCE AND INCIDENCE, DIAGNOSTICS AND TREATMENT OPTIONS ARE SPARSE. A SIGNIFICANT PROBLEM IN ANORECTAL PHYSIOLOGY TESTING IS A LACK OF PHYSIOLOGICALLY RELEVANT AND PRACTICAL DIAGNOSTIC TEST FOR IDENTIFYING THE UNDERLYING MECHANISMS TO IDENTIFY PROPER TREATMENT. CURRENT DIAGNOSTIC TESTS PROVIDE INCOMPLETE AND OFTEN CONFLICTING INFORMATION BECAUSE THEY DO NOT SIMULATE FECES OR THE DEFECATION PROCESS. NOT SURPRISINGLY, RESULTS OF THESE TESTS CORRELATE POORLY WITH SYMPTOMS AND TREATMENT OUTCOMES. BIOFEEDBACK THERAPY IS A WELL-ESTABLISHED THERAPY FOR OBSTRUCTED DEFECATION BUT DESPITE THE SUBSTANTIAL POTENTIAL AND PROMISING RESULTS, BIOFEEDBACK THERAPY IS ONLY DONE AT SPECIALIZED CENTERS AND SHOULD BE ADVANCED CLOSER TO THE POINT OF CARE. THE OBJECTIVE OF THIS SMALL R01 PROPOSAL IS TO MONITOR AND PREDICT THE OUTCOME OF BIOFEEDBACK THERAPY BASED ON UNPRECEDENTED INTEGRATED VISUAL FEEDBACK FROM THE NOVEL SIMULATED FECES DEVICE TERMED FECOBIONICS. THE DEVICE IS ELECTRONIC SIMULATED FECES THAT HAS THE CONSISTENCY AND SHAPE OF NORMAL STOOL. FECOBIONICS WILL PROVIDE MECHANISTIC UNDERSTANDING OF DEFECATION FOR THE EXAMINER BY VISUALIZING THE GEOMETRIC (CROSS-SECTIONAL AREA, BENDING AND SHAPE OF DEVICE) AND MANOMETRIC PROFILES OF THE SIMULATED FECES BEFORE AND DURING DEFECATION. THE CENTRAL HYPOTHESIS IS THAT THE FECOBIONICS DEVICE THAT MIMICS NATURAL DYNAMIC DEFECATION PROVIDES VALID DATA ON RECTAL EMPTYING ATTEMPTS FOR THE VARIOUS COMPONENTS OF THE DEFECATORY SYSTEM SUCH AS THE TONE OF ANAL SPHINCTERS AND PUBORECTALIS MUSCLE, AND ON MECHANOSENSORY PROPERTIES. THE OBJECTIVE IS TO MONITOR AND PREDICT BIOFEEDBACK THERAPY BASED ON MECHANISM-BASED AND HIGHLY INTEGRATED DATA THAT CAN BE VISUALIZED DURING ANORECTAL NEUROMUSCULAR EXERCISES. FOR THE PROPOSED STUDIES, WE WILL SELECT DYSSYNERGIA PATIENTS, WHO WILL BE MONITORED WITH FECOBIONICS BEFORE, DURING AND AFTER BIOFEEDBACK THERAPY. THE HYPOTHESIS IS FECOBIONICS DATA WILL CORRELATE BETTER TO SYMPTOMS BASED ON CONSTIPATION SCORES THAN CONVENTIONAL TECHNOLOGIES AND THAT SUCH DATA CAN BE USED TO PREDICT RESPONDERS AND NON-RESPONDERS TO THERAPY. OUR PROPOSAL SEEKS TO SHIFT CURRENT RESEARCH IN CONSTIPATION THERAPY BY USE OF A NOVEL DEVICE THAT PROVIDES MECHANISTIC INSIGHTS BY SIMULATING DEFECATION PATHOPHYSIOLOGICALLY AND EXAMINING THE MECHANISTIC CHANGES MULTI-DIMENSIONALLY: PRESSURE, DEFORMABILITY, BIOMECHANICS, AND TOPOGRAPHIC CHANGES TO MONITOR UNDERLYING DEFECTS IN PATIENTS WITH OBSTRUCTED DEFECATION, ESPECIALLY IN DYSSYNERGIA. THE UNIQUE ASPECTS OF OUR PROPOSAL ARE TO SIMULATE STOOL WITH A BIONICS DEVICE THAT INTEGRATES MULTIPLE VARIABLES THAT EXAMINE THE MECHANISTIC UNDERPINNINGS OF OBSTRUCTED DEFECATION. THE IMPACT OF THIS PROJECT IS TO SHED NEW UNDERSTANDING OF CONSTIPATION AND TO PREDICT RESPONDERS. THIS WILL FACILITATE DEVELOPMENT OF INNOVATIVE BOWEL MANAGEMENT PROGRAMS USING FECOBIONICS AS THE BIOFEEDBACK THERAPY TOOL.