关键词: App-based therapeutics Digital therapeutics Ehealth Erectile dysfunction Impotence Sexual health

来  源:   DOI:10.1016/j.euf.2024.05.020

Abstract:
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]).
UNASSIGNED: 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: 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.
RESULTS: A therapy app improved sexual function and overall well-being for men experiencing erectile dysfunction, leading to better quality of life.
摘要:
目的:虽然国际指南提倡采用多方面的方法来治疗涉及体力活动的勃起功能障碍(ED),心理支持,和教育,结构化程序很少见。为了解决这个差距,开发了一种基于应用程序的疗法,提供系统的方法。这个随机的,一项单盲对照试验旨在评估基于app的治疗改善ED的有效性.
方法:共有241例(49.74,标准差12.73年)ED(国际勃起功能指数[IIEF]-5<22)患者被随机分配到12周的应用基础治疗(治疗组[TG],n=122)或应用程序的等待列表,并继续其当前管理协议(控制组[CG],n=119)。包括长期服用ED药物的患者,但随后对开始新药物治疗的患者进行排除.共同终点是勃起功能(IIEF-5)从基线到12周的改善,疾病相关生活质量(QOL-Med-15),和患者激活(患者激活测量[PAM-13])。
勃起功能(IIEF-5)在TG组中提高了4.5分,而在CG组中提高了0.2分(p<0.0001,95%置信区间[CI]3.4-5.0)。TG组的生活质量(QOL-Med)比CG组的-0.0分提高了20.5分(p<0.0001,95%CI19.2-26.0)。与CG组的0.6分相比,TG组的患者激活(PAM-13)提高了11.2分(p<0.0001,95%CI9.1-13.6)。磷酸二酯酶5型抑制剂的摄入对所有观察到的治疗效果没有影响。
结论:基于App的ED患者治疗提供了显著的,有临床意义的改善。生活质量和患者激活也显著提高。该计划有可能改变ED治疗的临床实践。
结果:一种治疗应用程序改善了勃起功能障碍男性的性功能和整体健康状况,带来更好的生活质量。
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