A digital health program for treatment of urinary incontinence: retrospective review of real-world user data

• Published in: International Urogynecology Journal Vol. 34; no. 5; pp. 1083 - 1089
• Main Authors: Keyser, Laura E., McKinney, Jessica L., Pulliam, Samantha J., Weinstein, Milena M.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.05.2023; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Body mass index; Exercise Therapy; Female; Gynecology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Original; Original Article; Pelvic Floor; Quality of Life; Retrospective Studies; Telemedicine; Treatment Outcome; Urinary incontinence; Urinary Incontinence - therapy; Urinary Incontinence, Stress - diagnosis; Urinary Incontinence, Stress - therapy; Urinary Incontinence, Urge; Urology; Young Adult; Urinary incontinence; Digital therapeutics; Real-world evidence
• ISSN: 0937-3462; 1433-3023
• DOI: 10.1007/s00192-022-05321-3

Introduction and hypothesis To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. Methods This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020–December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t -test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. Results Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22–84, N  = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m 2 (range 15.2–46.9, N  = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 ( p  ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. Conclusions This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.