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) and patients with BPH and OAB (N40 + N32.8) in questions 2, 3 and 7 (question 2 and 3 p < 0.0001, question 7 p = 0.0015). According to the analysis of individual IPSS questions, the greatest improvements were observed in frequency, nocturia and the feeling of incomplete bladder emptying. Conclusion

These findings suggest that a structured app-based therapeutic may exert a stronger effect on storage symptoms than voiding symptoms in men with LUTS. This study confirms the value of the digital therapy as an integral part of the standard care for patients with male LUTS.