Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial.

Abstract

OBJECTIVE:To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI).METHODS:In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting.RESULTS:From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3–8) and 5 (3–8) episodes to 1 (0–3) and 2 (1–4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were “much improved” or “very much improved” on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21–3.15). There were no device-related severe adverse events.CONCLUSION:In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program.CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT04508153.FUNDING SOURCE:Renovia Inc.