High adherence and improved male lower urinary tract symptoms: A pilot study of the digital therapeutic Lutastic+

Objective: Lower urinary tract symptoms (LUTS) are highly prevalent in men. Despite guideline recommendations and proven efficacy of conservative first-line management, routine care remains largely medication-driven. Digital therapeutics integrating behavioral interventions and objective monitoring offer an accessible approach to deliver conservative management in a standardized format. This pilot study evaluated adherence, patient experience, motivation, and symptom improvement associated with a digital self-management therapy integrating automated bladder diary monitoring. Materials and Methods: In this prospective, single-arm pilot study, treatment-naïve men aged ≥40 years with bothersome LUTS (International Prostate Symptom Score [IPSS] ≥ 8 and/or Incontinence Questionnaire Overactive Bladder [ICIQ-OAB] ≥ 4) participated in a 12-week CE-certified digital therapeutic program (Lutastic+) with conservative therapy. The intervention integrated the Diary Pod, a smart urine collection device enabling automated data tracking. The primary outcome was adherence and engagement assessed via objective in-app usage data. Exploratory outcomes comprised changes in symptom severity (IPSS, ICIQ-OAB), bladder diary parameters, and quality of life (IPSS-QoL). Results: Thirty-three participants initiated the intervention, and 30 (91%) completed the 12-week program. Engagement was strong, with participants completing on average 75.4% of therapeutic exercises and 67.4% of daily educational tips, and reporting high motivation and positive experience. Mean IPSS decreased from 13.4 at baseline to 7.3 at week 12 (mean reduction: 6.1 points; −41.8%). Greater reductions were observed among participants with higher baseline severity (IPSS ≥ 14; −9.3 points). OAB symptoms and IPSS-QoL improved significantly. Conclusion: The digital therapeutic, integrating the Diary Pod for objective symptom tracking, demonstrated high adherence and engagement, with positive patient experience and motivation. Exploratory findings demonstrated clinically meaningful symptom improvement.