Lower urinary tract symptoms (LUTS) are highly prevalent in men and can significantly impair quality of life. Although international guidelines recommend conservative and behavioral interventions as first-line therapy (1), their implementation in routine clinical practice remains limited, with initial treatment still being predominantly medication-driven. Digital therapeutics may offer an accessible, and scalable solution by delivering standardized lifestyle and behavioral interventions. This pilot study aimed to evaluate adherence, patient engagement and motivation associated with a digital therapeutic for male LUTS incorporating an automated bladder diary for progress monitoring. In addition, exploratory analyses assessed its clinical potential to improve symptom severity and quality of life.

This prospective, single-arm pilot study included treatment-naïve men aged ≥40 years with bothersome LUTS, defined as IPSS ≥8 and/or ICIQ-OAB ≥4. Participants completed a 12-week CE-certified digital therapeutic program (Lutastic+) via a mobile application, providing guideline-recommended conservative management including lifestyle advice, behavioral therapy, guided pelvic floor exercises and bladder training.(2) The digital program has an integrated urine collection device (CE-marked Diary Pod) enabling automated bladder diary data capture (3). 

The primary outcome was treatment adherence and engagement using objective in-app usage metrics, and self-reported motivation. Secondary exploratory outcomes included changes in symptom severity (IPSS, ICIQ-OAB), bladder diary parameters, and disease-specific quality of life (IPSS-QoL). Descriptive and within-group analyses were performed.

Thirty-three participants initiated the program, of whom 30 (91%) completed the 12-week intervention. Engagement was high, with participants completing a mean of 75.4% of therapeutic exercises and 67.4% of daily educational content. Participants reported high intrinsic motivation and a positive user experience. At week 12, the program received a mean rating of 4.5/5, and 65.4% of participants indicated willingness to continue use for one year. A majority of participants reported that progress monitoring with the Diary Pod was useful (88.5%) and motivating (61.5%).

Mean IPSS decreased from 13.4 at baseline to 7.3 at week 12, corresponding to a reduction of 6.1 points (−41.8%). Greater improvements were observed in participants with higher baseline symptom severity (IPSS ≥14), with a mean reduction of 9.3 points. Significant improvements were also observed in quality of life (IPSS-QoL) and overactive bladder symptoms (ICIQ-OAB; −23.5% reduction). Bladder diary parameters showed trends toward improvement, including increased functional bladder capacity (+63.3 mL), reduced daytime frequency (−1.5 voids/day), and reduced nighttime frequency (−0.5 voids/night).

This pilot study demonstrated that a digital therapeutic combining behavioral interventions with objective progress monitoring is feasible and associated with high adherence and engagement in men with LUTS. The observed symptom improvements exceeded established thresholds for clinical meaningful differences and were accompanied by improvements in quality of life, supporting the potential effectiveness of digitally delivered conservative management.

The integrated Diary Pod was perceived as useful and motivating, as it enabled visualization of individual progress through objective data. This suggests that automated progress monitoring add value beyond app-based education alone and may support engagement with behavioral therapy.

Given the exploratory design and absence of a control group, these results should be confirmed in a larger randomized controlled study to confirm efficacy and long-term outcomes.

A 12-week digital therapeutic program for male LUTS demonstrated high adherence, strong patient engagement, and clinically meaningful symptom improvement. These findings support the potential of digital therapeutics as an accessible and scalable approach to deliver guideline-recommended conservative management as first-line therapy.

Cornu JN, Gacci M, Hashim H, Herrmann TRW, Malde S, Netsch C, et al. EAU Guidelines (Management of Non-Neurogenic Male Lower Urinary Tract Symptoms). EAU Annual Congress Paris: 2024.
Drake MJ, Worthington J, Frost J, Sanderson E, Cochrane M, Cotterill N, et al. Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial. BMJ 2023;e075219.
Schulte-Baukloh H, Weiss C, Höppner D, Haberecht K, Borgmann H, Ralla B, Weinberger S, Schlomm T, Brown A, Vermeulen Z. Real-Life Monitoring: Precise Onset of Action after BotulinumtoxinA Injection. JU Open Plus 3(5):e00038, May 2025.

Continence 19S (2026) 102561
DOI: 10.1016/j.cont.2026.102561