Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men Using a Mobile App (PERSONAL): Feasibility and Usability Study

Abstract

Background Continuous α1a-blockade is the first-line treatment for lower urinary tract symptoms (LUTS) among older men with suspected benign prostatic hyperplasia. Variable efficacy and safety for individual men necessitate a more personalized, data-driven approach to prescribing and deprescribing tamsulosin for LUTS in older men. Objective We aim to evaluate the feasibility and usability of the PERSONAL (Placebo–Controlled, Randomized, Patient-Selected Outcomes, N-of-1 Trials) mobile app for tracking daily LUTS severity and medication side effects among older men receiving chronic tamsulosin therapy. Methods We recruited patients from the University of California, San Francisco health care system to participate in a 2-week pilot study. The primary objectives were to assess recruitment feasibility, study completion rates, frequency of symptom tracking, duration of tracking sessions, and app usability rankings measured using a follow-up survey. As secondary outcomes, we evaluated whether daily symptom tracking led to changes in LUTS severity, perceptions of tamsulosin, overall quality of life, medication adherence between baseline and follow-up surveys, and perceived app utility. Results We enrolled 19 men within 23 days, and 100% (19/19) of the participants completed the study. Each participant selected a unique combination of symptoms to track and recorded data in the PERSONAL app, with a median daily completion rate of 79% (11/14 days). The median duration of the app session was 44 (IQR 33) seconds. On a scale of 1 (strongly disagree) to 5 (strongly agree), the participants reported that the PERSONAL app was easy to use (mean 4.3, SD 1.0), that others could learn to use it quickly (mean 4.2, SD 0.9), and that they felt confident using the app (mean 4.4, SD 0.8). LUTS severity, quality of life, and medication adherence remained unchanged after the 2-week study period. Fewer men were satisfied with tamsulosin after using the app (14/19, 74% vs 17/19, 89% at baseline), although the perceived benefit from tamsulosin remained unchanged (18/19, 95% at baseline and at follow-up). In total, 58% (11/19) of the participants agreed that the PERSONAL app could help people like them manage their urinary symptoms. Conclusions This pilot study demonstrated the high feasibility and usability of the PERSONAL mobile app to track patient-selected urinary symptoms and medication side effects among older men taking tamsulosin to manage LUTS. We observed that daily symptom monitoring had no adverse effects on the secondary outcomes. This proof-of-concept study establishes a framework for future mobile app studies, such as digital n-of-1 trials, to collect comprehensive individual-level data for personalized LUTS management in older men.

Personalized Data Science and Personalized (N-of-1) Trials: Promising Paradigms for Individualized Health Care

“…Although the multichannel biosensors used in this study might be beyond the means of home-based Per-DS investigators, systematic monitoring using personal devices (wearable or not) for heart rate and body temperature is feasible for many. Lee et al (2021) demonstrated the feasibility for older men receiving chronic tamsulosin therapy to manage lower urinary track symptoms (LUTS) to monitor their urinary symptoms and medication side effects using a mobile app. Daily symptom monitoring had no adverse effects on the secondary outcomes.…”

“… Lee et al (2021) demonstrated the feasibility for older men receiving chronic tamsulosin therapy to manage lower urinary track symptoms (LUTS) to monitor their urinary symptoms and medication side effects using a mobile app. Daily symptom monitoring had no adverse effects on the secondary outcomes.…”

Mobile health: a promising tool for the management of male patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

“…Patients were not divided between first-visit and follow-up group. Kim, 2022 [ 8 ] Korea Healthy Bladder-VD (Soundable Health, Inc.) 78 55 (40–65)° Higher scores in the convenience and satisfaction area were reported by patients using the mobile app VD compared to those using the paper-based VD. Overall preference for using the mobile app instead of the paper-based VD: 9 out of 10 (7.82 ± 2.68).…”

“…Similarly, the PERSONAL mobile app was tested for tracking LUTS severity and side effects of medical therapy in older men with favorable results [ 8 , 9 ].…”