App-Based Interventions for Fecal Incontinence: App Usability, User Engagement, and Global Improvement

INTRODUCTION: Behavior modification and pelvic floor muscle exercises are first-line therapy for incontinence but require significant patient motivation. Digital therapeutics have emerged to support patients in this work, and are well-described for urinary incontinence, but fewer data exist about their use for fecal incontinence (FI) and among older patients. One digital therapeutic pelvic health system, cleared by the Food and Drug Administration (FDA) for prescription use at home, consists of an intravaginal motion-based wand paired with an app on the user’s smartphone to facilitate home biofeedback therapy. Users are instructed to use the system daily and remote health coaching is available for all users. OBJECTIVE: (1) To describe usability and characterize parameters of digital therapeutic use (adherence and engagement with health coaching) among participants in a trial using a pelvic health system for treatment of FI. (2) To describe how parameters of use and symptom improvement vary by user age. METHODS: We analyzed data from a cohort of 23 women currently enrolled in a clinical trial evaluating the use of a digital therapeutic pelvic health system for treatment of FI. Figure 1 depicts inclusion and exclusion criteria. Participants completed the mHealth App Usability Questionnaire (MAUQ), the Global Perception of Improvement (GPI), the Patient Satisfaction Question (PSQ), and the Patient Estimated Percent Improvement (EPI) 16 weeks after enrollment. Adherence to the prescribed daily exercise regimen (2.5 minutes per day two times per day) was ascertained using motion sensor data; number of health coach interactions per week during treatment was ascertained from health coach logs. Ordinary least squares regression was utilized to assess linear trends by age. RESULTS: All participants identified as non-Hispanic White, with mean age 61.0 ± 17.6 years and mean body mass index 29.12 ± 8.15 kg/m2. Usability, engagement, and improvement at 16 weeks are presented in Table 1. Usability was high based on MAUQ responses and mean adherence to device use for the prescribed exercise regimen was over 70%, with mean of 1 health coach interaction per week. Older participants utilized coaches and adhered to device use more than younger participants (Figure 2), and estimated percent improvement remained stable across age groups at 60%. CONCLUSIONS: Usability, engagement, and symptom improvement were high among participants of all ages in an ongoing trial using a digital therapeutic to support home biofeedback for treatment of FI. Older women were more likely to adhere to treatment recommendations and to use a health coach, but symptom improvement was stable across age groups.