Evaluating Differential Impact of Digital Therapy for Male LUTS: Insights from the BEST Trial Subgroup Analysis

Purpose: Men with lower urinary tract symptoms (LUTS) represent a heterogeneous patient population. The BEST trial investigated the effectiveness of a digital health application for male LUTS. This pre-specified subgroup analysis evaluated treatment effects based on key clinical characteristics and additionally reports micturition diary outcomes and adherence data. Methods: In this randomized controlled trial, 237 patients were assigned to either the intervention group (IG, n=112), receiving app-based therapy (Kranus Lutera) alongside standard care, or the control group (CG, n=125), receiving standard care alone. Primary endpoints included 12-week changes in the International Prostate Symptom Score (IPSS) and both subscales of the Overactive Bladder Questionnaire Short Form (OAB-q SF). Subgroup analyses were stratified by diagnosis (OAB, BPH, OAB+BPH), baseline symptom severity, age (≤60, >60 years), and concurrent pharmacological treatment. Additional outcomes included changes in daytime/nighttime voiding frequency and urgency episodes. German Clinical Trials Registry number: DRKS00030935. Results: Subgroup analyses showed consistent improvements after 12 weeks in favour of the IG across diagnoses (between-group differences IPSS -6.4 to -7.4), with the largest improvement in severe LUTS (-10.7; 95% CI -12.7;-8.6, p<0.0001). Patients benefited regardless of age or medication use. These findings were further supported by improvements in OAB scores. Micturition diaries showed reduced daytime (-1.33), nighttime (-0.18), and urgency episodes (-1.59). In the IG, 84% of participants used the app several times per week. Conclusion: The digital therapeutic achieved clinically meaningful symptom and quality-of-life improvements across all subgroups. Additional reductions in voiding frequency and high adherence support its broad applicability in clinical practice.