{"title":"[良性前列腺综合症的数字健康]","authors":"Sandra Helen Schönburg","doi":"10.1055/a-2573-7302","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":7513,"journal":{"name":"Aktuelle Urologie","volume":" ","pages":""},"PeriodicalIF":0.3000,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[Digital health for benign prostate syndrome].\",\"authors\":\"Sandra Helen Schönburg\",\"doi\":\"10.1055/a-2573-7302\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":7513,\"journal\":{\"name\":\"Aktuelle Urologie\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.3000,\"publicationDate\":\"2025-05-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Aktuelle Urologie\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1055/a-2573-7302\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Aktuelle Urologie","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1055/a-2573-7302","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
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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