Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial.

IF 1.9 3区医学 Q4 ANDROLOGY

Translational andrology and urology Pub Date : 2024-10-31 Epub Date: 2024-10-28 DOI:10.21037/tau-24-329

Moritz Lange, David Charles, Aisha Kazeem, Marieke Jones, Fionna Sun, Soutik Ghosal, Sarah Krzastek, David Rapp, Nicolas Ortiz, Ryan Smith

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引用次数: 0

Abstract

Background: Low-intensity shockwave therapy (LiSWT) is an emerging non-invasive and restorative therapy for erectile dysfunction (ED) with demonstrated efficacy and few adverse events. Although LiSWT has been shown to improve erectile function amongst men with ED, few studies have examined its long-term durability. We present the long-term results of a randomized controlled trial (RCT) assessing erectile function after LiSWT.

Methods: A total of 30 patients with baseline ED seen at the University of Virginia were randomized to LiSWT or sham treatment. Patients in the sham group crossed over at 1 month and were unblinded. After initial trial completion, patients enrolled in the long-term outcome study were considered one combined cohort. Patients were treated twice weekly for 3 consecutive weeks with a Storz^® Duolith™ device delivering 3,000 shockwaves at 0.1 mJ/mm² to the distal penis, the base of the penis, and the crura. Primary outcomes were changes in Sexual Health Inventory for Men (SHIM) and Erection Hardness Score (EHS) from baseline (3 months pre-treatment) up to 36 months post-treatment. Changes in SHIM and EHS scores were evaluated using linear mixed effects models. Patient satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index.

Results: The mean baseline SHIM score was 10.8±0.94. At 12-, 24-, and 36-month assessment following treatment, the mean SHIM scores were 15.6±1.27 (P<0.001), 15.0±1.14 (P<0.001), and 12.2±1.43 (P=0.31). The mean baseline EHS score was 1.87±0.17. At 12-, 24-, and 36-month assessment following treatment, the mean EHSs were 2.70±0.24 (P<0.001), 2.66±0.21 (P<0.001), and 2.29±0.26 (P=0.10). The median [interquartile range (IQR)] EDITS score was 48.9 (22.7, 74.4), indicating moderate satisfaction with LiSWT. There were no adverse events recorded.

Conclusions: Our analysis demonstrates sustained long-term improvement in erectile function after LiSWT for a heterogeneous cohort. While limited by population size, the results suggest durable improvement in erectile function for the first 2 years with a peak treatment effect at 1 year. Treatment effect appears to decline between 2 and 3 years.

Clinical trial registration: ClinicalTrials.gov, NCT04434352.

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低强度冲击波疗法治疗勃起功能障碍是否是一种持久的治疗方案？

背景：低强度冲击波疗法（LiSWT）是一种新兴的治疗勃起功能障碍（ED）的非侵入性恢复疗法，疗效显著，不良反应少。虽然 LiSWT 已被证明能改善 ED 男性患者的勃起功能，但很少有研究对其长期持久性进行了考察。我们将介绍一项随机对照试验（RCT）的长期结果，评估LiSWT治疗后的勃起功能：方法：在弗吉尼亚大学就诊的 30 名基线 ED 患者被随机分配接受 LiSWT 或假治疗。假治疗组患者在 1 个月后进行交叉治疗，不设盲法。初次试验结束后，参加长期结果研究的患者被视为一个综合组群。患者使用 Storz® Duolith™ 设备对阴茎远端、阴茎根部和阴茎嵴进行连续 3 周、每周两次的治疗，每次 3000 次冲击波，每次 0.1 mJ/mm2。主要结果是男性性健康量表（SHIM）和勃起硬度评分（EHS）从基线（治疗前 3 个月）到治疗后 36 个月的变化。SHIM 和 EHS 分数的变化采用线性混合效应模型进行评估。患者满意度采用勃起功能障碍治疗满意度量表（EDITS）指数进行评估：基线 SHIM 平均得分为 10.8±0.94。在治疗后 12 个月、24 个月和 36 个月的评估中，SHIM 平均得分为 15.6±1.27（PC 结论：我们的分析表明，患者的勃起功能得到了持续、长期的改善：我们的分析表明，在对不同人群进行 LiSWT 治疗后，勃起功能得到了长期持续的改善。虽然受到人群规模的限制，但结果表明勃起功能在头两年内得到了持久改善，治疗效果在 1 年达到峰值。治疗效果似乎在2至3年间有所下降：临床试验注册：ClinicalTrials.gov，NCT04434352。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Translational andrology and urology Medicine-Urology

CiteScore

4.10

自引率

5.00%

发文量

期刊介绍： ranslational Andrology and Urology (Print ISSN 2223-4683; Online ISSN 2223-4691; Transl Androl Urol; TAU) is an open access, peer-reviewed, bi-monthly journal (quarterly published from Mar.2012 - Dec. 2014). The main focus of the journal is to describe new findings in the field of translational research of Andrology and Urology, provides current and practical information on basic research and clinical investigations of Andrology and Urology. Specific areas of interest include, but not limited to, molecular study, pathology, biology and technical advances related to andrology and urology. Topics cover range from evaluation, prevention, diagnosis, therapy, prognosis, rehabilitation and future challenges to urology and andrology. Contributions pertinent to urology and andrology are also included from related fields such as public health, basic sciences, education, sociology, and nursing.