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Abstract
In addition to drugs, remedies and medical aids, digital health applications are a new therapeutic area according to §33a SGB V. There are now 69 approved DiGA listed in the BfArM DiGA directory, 40 of them permanently. The approval and listing of a DiGA is the result of a randomised control trial (RCT) with corresponding proof of effectiveness. Kranus Lutera is the first approved DiGA for male lower urinary tract symptoms (LUTS). The BEST study provided proof of effectiveness. A total of 237 patients were randomised in this study. Compared to the control group, the intervention group showed a significant improvement in the primary endpoint IPSS (-7.0; 95% CI: -8.1; -5.9; p<0.0001) and the secondary endpoints OAB-q-SF part 1 (symptom burden: -18.6; 95% CI: -22.2; -15.0; p<0.0001) and part 2 (health-related quality of life: +17.2; 95% CI: 20.16; 14.8; p<0.0001). The two subgroups (BPH, OAB) benefited similarly.
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