(Poster 69) Real World Evidence for a Digital Pelvic Health System for Fecal Incontinence

Objectives: To evaluate real-world outcomes among women using a digital therapeutic pelvic health system to support management of fecal incontinence (FI). The study assessed changes in symptom severity, as measured by the Colorectal Anal Distress Inventory (CRADI-8), and explored associations between adherence, user characteristics, pelvic floor function and patient-reported improvement.

Methods: This retrospective cohort study analyzed de-identified commercial data from female users of a digital therapeutic pelvic health system designed to support pelvic floor muscle training (PFMT). Eligible users initiated therapy between July 1, 2023—August 1, 2024, were ≥18 years of age, received either a clinical FI diagnosis or self-reported FI symptoms, and completed a baseline CRADI-8 assessment along with at least one follow-up beyond four weeks. Demographic, clinical, and device usage data were analyzed. Adherence was quantified by weekly use. Pelvic floor performance metrics (e.g., angle change, contraction hold time) were used to assess functional changes. The primary outcome was the change in CRADI-8 score from baseline to 8-weeks. Secondary outcomes included CRADI-8 score change at 4- and 12-weeks, adherence trends, pelvic floor muscle performance, and responses on the Patient Global Impression of Improvement (PGI-I). Subgroup analyses compared users with a clinical diagnosis to those with self-reported symptoms. The study was exempt from review by the Western-Copernicus Group Institutional Review Board under 45 CFR § 46.104(d)(4).

Results: A total of 278 users met inclusion criteria; 260 self-reported FI symptoms and 18 had a clinical FI diagnosis. Mean age was 56.9 years, mean body mass index was 27.7 kg/m2, and 77% identified as white and non-Hispanic. Baseline CRADI-8 scores were significantly higher among those with a clinical diagnosis; otherwise, groups were similar. Mean CRADI-8 score change from baseline to 8-weeks was -8.5 points (SD 15.5, p< 0.0001); -13.4 points (SD 15.6) for those with a clinical FI diagnosis and -8.1 points (SD 15.5) for the self-report group (Table 1). Users with a clinical diagnosis demonstrated greater average symptom improvement. At 8-weeks, 64.3% of FI diagnosis group and 58.9% of the self-report group met the CRADI-8 minimum important difference (MID) of -5 points. Of 142 PGI-I responses, 72.5% (103) reported ‘a little,’ ‘much,’ or ‘very much’ better. Treatment adherence was high (100%=14 uses/week); Figure 1 illustrates weekly adherence and CRADI-8 scores over time.

Conclusions: Use of a digital therapeutic pelvic health system was associated with meaningful improvements in fecal incontinence symptoms among women in a real-world setting. Over half of users achieved clinically important symptom reduction by 8 weeks, with greater improvements observed among those with a clinical diagnosis of FI. High user engagement and reported improvement support the potential of this approach to expand access to conservative FI management.

Figure 1. Average weekly device usage and mean survey scores on the Colorectal Anal Distress Inventory, Short Form (CRADI-8) at 4-, 8-, and 12-weeks.