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[Digital health applications in urology].

Sandra Schönburg^1,2, Christian Gratzke³, Kurt Miller⁴

¹Urologische Universitätsklinik Halle, Martin Luther University, Ernst-Grube-Straße 40, Halle (Saale), Deutschland. sandra.schoenburg@uk-halle.de.

Urologie (Heidelberg, Germany)

|August 12, 2024

Summary

Digital health applications (DiGA) are now prescribed in Germany, with two urology-focused options for erectile dysfunction and BPH/OAB showing significant patient benefits. These innovative digital therapies offer new multimodal treatment combinations.

Keywords:

Benign prostatic hyperplasia Clinical studies Erectile dysfunction Lower urinary tract symptoms Overactive bladder

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Ultrasonography of the Adult Male Urinary Tract for Urinary Functional Testing

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Area of Science:

Urology
Digital Health
Health Economics

Context:

Digital health applications (DiGA) were integrated into the German healthcare system in 2020.
DiGA are prescription-based and reimbursed by statutory and private health insurance.
Two DiGA are currently available for urological conditions: erectile dysfunction and benign prostatic hyperplasia/overactive bladder (BPH/OAB).

Purpose:

To present the legal framework, clinical evidence, and practical application of DiGA in urology.
To review the regulatory requirements, mode of action, and clinical trial outcomes of urological DiGA.
To examine the prescribing practices and integration of DiGA into patient care.

Summary:

Since 2020, 63 DiGA have been registered by the BfArM, with 35 approved definitively.
Two urological DiGA target erectile dysfunction and BPH/OAB, demonstrating significant and clinically relevant patient benefits in randomized controlled trials.
Additional urological DiGA are undergoing clinical development, indicating a growing field.

Impact:

DiGA introduce novel multimodal therapy combinations previously unavailable in clinical practice.
These digital interventions provide multidimensional benefits for patients, enhancing treatment outcomes.
The successful implementation of urological DiGA signifies a shift towards digital therapeutics in specialized healthcare.