A Randomized Non-Inferiority Trial for Telemedicine in the Follow-Up of Overactive Bladder Patients.

Abstract

Purpose: Despite the increasing use of telemedicine in Urology, regulatory barriers and lack of care-team training have limited its imprint on healthcare delivery. We designed a non-inferiority trial to delineate the use-case of telemedicine in the management of overactive bladder. This prospective, randomized controlled trial aims to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits, evaluating effectiveness, patient satisfaction, safety, and cost metrics.

Materials and methods: Men and women with idiopathic (non-neurogenic) overactive bladder were prospectively enrolled and randomized to either the telemedicine or in-person arm. Participants completed standardized surveys at baseline and up to 6 consecutive follow-up visits to assess response to treatment and satisfaction. The primary outcome was patient satisfaction with treatment (Treatment Satisfaction Visual Analogue Scale, TS-VAS); secondary outcomes included OAB-q SF Symptom Bother Scale, PGI-I, PGI-S, safety, patient burden (time and out-of-pocket costs), and progression to minimally invasive therapy. Intent-to-treat analysis was conducted to compare the arms with Fisher's exact, Median, and Kruskal-Wallis tests.

Results: Of the 164 participants enrolled, the analytic cohort was comprised of 147 with at least one follow-up visit: 80 in the telemedicine arm (232 visits) and 67 in the in-person arm (208 visits). The cohort was primarily female. There were no differences in demographics or clinical characteristics across arms. Treatment satisfaction at last visit was high across both arms, and telemedicine was found to be non-inferior to in-person (TS-VAS: IP 83.0 vs. T 80.0, p = 0.42). PGI-I and PGI-S were similarly non-inferior. There was no difference in OAB-q (p = 0.99) or rate of progression to minimally invasive therapies. Total burden for patients, measured in hours of travel, missed work, and cost, favored telemedicine. Utilization of urgent care, ER, or outside provider care visits for one's bladder condition was higher in the IP arm (10.4% vs. 1.3%, p = 0.024). There was no difference in rate of loss to follow-up.

Conclusions: In this prospective, randomized trial, the telemedicine approach for the management of OAB was found to be non-inferior across patient satisfaction and efficacy, while comparing favorably in decreasing patient burden. Interestingly, the composite measure of safety showed higher utilization of outside care in the in-person cohort. Telemedicine offers an alternative option for care delivery for OAB that may result in improved satisfaction and compliance, and decreased cost, time, and travel burden for patients, allowing urologists to extend care to rural communities and non-mobile patients.