Evaluating the impact of digital therapy for male LUTS: insights from the BEST trial subgroup analysis

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.

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.

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.

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.