App-based Therapy of Erectile Dysfunction Using a Digital Health Application (EDDIG Study): A Randomized, Single-blind, Controlled Trial.
作者信息
Kliesch Sabine, Cremers Jann-Frederik, Krallmann Claudia, Epplen Robin, Scheffer Bettina, Schubert Tim, Schubert Maria, Dreger Nici Markus, Raschke Ralph, Khaljani Ehsan, Maxeiner Andreas, Miller Kurt, Wiemer Laura, Zitzmann Michael
机构信息
Centre of Reproductive Medicine and Andrology, Department of Clinical and Surgical Andrology, University Clinic Münster, Münster, Germany.
Centre of Reproductive Medicine and Andrology, Department of Clinical and Surgical Andrology, University Clinic Münster, Münster, Germany.
出版信息
Eur Urol Focus. 2024 Dec;10(6):1003-1010. doi: 10.1016/j.euf.2024.05.020. Epub 2024 Jun 8.
BACKGROUND AND OBJECTIVE
While international guidelines advocate for a multifaceted approach to treating erectile dysfunction (ED) involving physical activities, psychological support, and education, structured programs are infrequent. To address this gap, an app-based therapy was developed, offering a systematic approach. This randomized, single-blind controlled trial aimed to assess the effectiveness of an app-based therapeutic in improving ED.
METHODS
A total of 241 patients (49.74, standard deviation 12.73 yr) with ED (International Index of Erectile Function [IIEF]-5 <22) were randomized to the 12-wk app-based therapy (treatment group [TG], n = 122) or a waiting list for the app with continuation of their current management protocol (control group [CG], n = 119). Patients on long-term medication for ED were included, but subsequent exclusion occurred for those starting new medication. Coprimary endpoints were improvements from baseline to 12 wk in erectile function (IIEF-5), disease-related quality of life (QOL-Med-15), and patient activation (Patient Activation Measure [PAM-13]).
KEY FINDINGS AND LIMITATIONS
Erectile function (IIEF-5) improved by 4.5 points in the TG versus 0.2 points in the CG (p < 0.0001, 95% confidence interval [CI] 3.4-5.0) group. Quality of life (QOL-Med) improved by 20.5 points in the TG versus -0.0 points in the CG (p < 0.0001, 95% CI 19.2-26.0) group. Patient activation (PAM-13) improved by 11.2 points in the TG versus 0.6 points in the CG (p < 0.0001, 95% CI 9.1-13.6) group. Phosphodiesterase type 5 inhibitor intake had no influence on all observed treatment effects.
CONCLUSIONS AND CLINICAL IMPLICATIONS
App-based therapy of patients with ED provided a significant, clinically meaningful improvement. Quality of life and patient activation were also enhanced significantly. This program has the potential to change clinical practice in the treatment of ED.
PATIENT SUMMARY
A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.
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