Urologie (Heidelberg, Germany) · 2024
[Digital health applications in urology].
Аннотация на английскомСтатьяОбзорНазвание и аннотация: Перевод в очереди
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Schönburg Sandra, Gratzke Christian, Miller Kurt, Wiemer Laura, Kliesch Sabine
Аннотация
BACKGROUND: Digital health applications (DiGA) were included in the German healthcare system in 2020. They are available for prescription and reimbursed by public and private insurance companies. For the specialty of urology, there are currently two DiGA available: for the treatment of erectile dysfunction and benign prostatic hyperplasia/overactive bladder (BPH/OAB). The legal basis, clinical results and practical implementation are presented.
METHODS: Evaluation of websites and publications to show the regulatory requirements, mode of action, results of clinical trials and prescribing practice with DiGA.
RESULTS: Since 2020, 63 DiGA have been listed in the register of the Federal Office for Drugs and Medical Devices (BfArM), 35 of them definitively. Two urological DiGA aim to treat erectile dysfunction and BPH/OAB. Randomized, controlled studies have shown a significant and clinically relevant patient benefit for both DiGA. Further urological DiGA are in clinical development.
CONCLUSIONS: DiGAs offer multimodal therapy combinations that have not yet been used in clinical practice and show a multidimensional benefit for the patient.
METHODS: Evaluation of websites and publications to show the regulatory requirements, mode of action, results of clinical trials and prescribing practice with DiGA.
RESULTS: Since 2020, 63 DiGA have been listed in the register of the Federal Office for Drugs and Medical Devices (BfArM), 35 of them definitively. Two urological DiGA aim to treat erectile dysfunction and BPH/OAB. Randomized, controlled studies have shown a significant and clinically relevant patient benefit for both DiGA. Further urological DiGA are in clinical development.
CONCLUSIONS: DiGAs offer multimodal therapy combinations that have not yet been used in clinical practice and show a multidimensional benefit for the patient.