Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design.

OBJECTIVE To compare the efficacy of an Intravaginal Motion-Based Digital Health System (PDHS) compared to standardized Pelvic Floor Muscle Training (PFMT) for the treatment of stress or stress-predominant urinary incontinence (SUI). METHODS This is a virtually conducted prospective randomized controlled trial. The primary outcomes are change in urinary incontinence episodes by 3-day bladder diary and change in Urogenital Distress Inventory-6 score, measured at 8 weeks. Secondary outcomes include: Patient Global Impression of Severity (PGI-S), PGI-Improvement (PGI-I), Pelvic Floor Distress Inventory-20(PFDI-20), Pelvic Floor Impact Questionnaire-7(PFIQ-7), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-IR), Short Form-2 (SF-20), and assessment of adverse event (AE). Subjects are randomized 1:1 to an intervention group using leva PDHS for PFMT or a control group, using a home Kegel exercise program. Sample size needed to identify a 60% difference in incontinence episodes from baseline to 8 weeks post-randomization using alpha = 0.05, and a power of 0.8 is 156 subjects. To identify a 30% difference in the UDI-6 score from Baseline to Week 8 (alpha = 0.05, power = 0.8, using a one-tailed t-test) the needed sample size is 278, and allowing for an attrition rate of 15%, will require approximately 350 subjects, providing power to detect differences in both primary outcomes. RESULTS Recruitment was initiated September 2020 and is on target to date. The trial is projected to be complete in 2021and is registered at clinicaltrials.govNCT04508153. CONCLUSION This novel virtual recruitment approach may provide more efficient recruitment of large numbers of subjects and provide input into the use of app-based management of pelvic floor interventions.