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 powe

SUBMITTER: Weinstein MM 

PROVIDER: S-EPMC8936159 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature