Digital therapeutic device more effective than standard at-home exercise program to reduce female stress urinary incontinence

Reference

Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital therapeutic device for urinary incontinence. Obstet Gynecol 2022;139(4):606-615.

Synopsis

This randomized controlled trial compared at-home pelvic floor muscle training guided either by a motion-based digital therapeutic device or by standard written and narrated instructions to treat female stress urinary incontinence (SUI) and stress-predominant mixed SUI. The investigators conducted the study virtually during the COVID-19 pandemic without physical examination of participants. Enrollment was from October 2020 through March 2021. The authors recruited participants through widely used social media applications and paid each one $350 for participation over an 8-week study period. Eligible women (N = 363) were at least 18 years old with a minimum of at least 2 SUI incidents over 3 days as assessed by a bladder diary. The presence of SUI and mixed SUI was based on responses to the standardized Medical, Epidemiological, and Social aspects of Aging (MESA) questionnaire. The stress incontinence score had to be greater than the urge incontinence score. The intervention digital device detects pelvic floor motion and provides feedback to the user through a smart phone application that displays correct and incorrect motion. According to study group allocation, the participants were mailed the device and exercise instructions, or exercise instructions alone. The authors collected questionnaire data at baseline, 4 weeks, and 8 weeks. Analysis was by modified intention to treat and included all women who reported data at 8 weeks (n = 299). Baseline characteristics were similar between groups. Both groups improved over the study period based on the Urinary Distress Inventory, Short Form (UDI-6) scores with relatively greater mean improvement in the device group, from 53 +/- 20 to 36 +/- 21 vs 55 +/- 20 to 43 +/- 19 (P = .01). More participants in the device group reported at least a 50% reduction in SUI episodes: 59/143 (41%) vs 37/139 (27%) (odds ratio 1.70; 95% CI 1.03 - 2.81).