Defecatory disorders are common affecting up to 8% of the population. Rome IV diagnostic criteria are used to define this condition and, therefore, select patients for the gold standard therapy, anorectal biofeedback. The aim of this study was to test the current Rome IV Functional Defecation Disorder (FDD) criteria in a real-world population by using the response to biofeedback as a validation tool. A total of 485 patients (female 437, mean age 50 ± 17.6 years) with defecatory symptoms presenting to a neurogastroenterology clinic underwent anorectal biofeedback therapy regardless of whether they met formal Rome IV FDD criteria or not. Patients were assessed extensively with the Rome questionnaire, constipation questionnaire, and visual analog scales for satisfaction, control, quality of life, and anorectal manometry. Rome IV FDD was no better at predicting response to biofeedback compared with non-Rome IV FDD ( P = NS). Digitation ( P = 0.043) and increasing cumulative number of defecatory symptoms ( P = 0.038) were correlated with improvement in biofeedback (≥2-point increase in bowel satisfaction). Those with abnormal physiology only responded well to biofeedback (83% response rate), but this was not statistically different from no Rome IV physiology patients (73%). There was a trend for increasing cumulative number of abnormal physiology factors to correlate with biofeedback ( P = 0.086). Rome IV symptom criteria need revision to include more defecatory symptoms, include all subtypes of irritable bowel syndrome, and be inclusive of those with either loose stools or more frequent stools such as those previously labeled with "pseudodiarrhea" or "hyperdefecation." Continuing to include physiology criteria in the Rome diagnosis of FDD seems valid.
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