Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men using the PERSONAL app: Feasibility and Usability Study (Preprint)
BACKGROUND Continuous alpha 1a-blockade is first-line management for lower urinary tract symptoms (LUTS) amongst older men with suspected benign prostatic hyperplasia (BPH). 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 aimed to evaluate the feasibility and usability of using 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 healthcare system to participate in a two-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, and medication adherence between baseline and follow-up surveys as well as perceived app utility. RESULTS We enrolled 19 men within 23 days and 100% of participants completed the study. Each participant selected a unique combination of symptoms to track and recorded data in the PERSONAL app a median of 11 out of 14 days (79% daily completion rate). Median app session duration was 44 seconds (IQR: 33). On a scale of 1 (“Strongly Disagree”) to 5 (“Strongly Agree”), participants reported that the PERSONAL app was easy to use (mean=4.3, standard deviation [SD]=1.0), others could learn to use it quickly (mean=4.2, SD=0.9), and 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 participants versus 17/19 participants at baseline), although perceived benefit from tamsulosin remained unchanged (95% at baseline and at follow-up). 58% of men agreed that the PERSONAL app can help people like them manage their urinary symptoms. CONCLUSIONS This pilot study demonstrated high feasibility and usability of the PERSONAL mobile app to track patient-selected urinary symptoms and tamsulosin side effects among older men taking tamsulosin for LUTS. We observed no adverse consequences of daily symptom monitoring on our 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.