JMIR Publications

ABSTRACT

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.