Differential impact of digital therapy on storage and voiding LUTS: A post‐hoc IPSS analysis from the BEST randomized controlled trial
Abstract
Objective: To investigate whether storage or voiding symptoms respond more favourably to the use of Kranus Lutera, the first app-based digital therapeutic for male lower urinary tract symptoms (LUTS), using detailed item-level analysis of the IPSS questionnaire. Materials and Methods: The present data represent a post-hoc analysis of the results of the BEST trial, a randomized controlled study evaluating the efficiency of the digital therapy Kranus Lutera. The study period lasted 12 weeks, conducted between 04/2023 and 11/2023. We assessed the mean change from baseline to 12 weeks for each of the seven IPSS items. Voiding symptoms (items 1, 3, 5 and 6) and storage symptoms (items 2, 4 and 7) were analysed separately. Results: Participants using the digital therapeutic demonstrated statistically significant improvements across all IPSS items. Compared to the control group, the intervention group showed a significant and clinically relevant improvement in the primary endpoint (IPSS), with an overall reduction of -7.0 points (95% CI: -8.1 to -5.9, p < 0.0001). Notably, improvements in storage symptoms were consistently larger than those in voiding symptoms. The analysis of individual IPSS questions showed the greatest changes in the overall cohort for questions 1, 2 and 7 (each p < 0.0001). Patients with the single diagnosis BPH (N40) showed the greatest score reduction in questions 2 and 5 (each p < 0.0001), patients with OAB (N32.8) in questions 2, 4 and 7 (each p < 0.0001)…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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