Lange Moritz, Charles David, Kazeem Aisha, Jones Marieke, Sun Fionna, Ghosal Soutik, Krzastek Sarah, Rapp David, Ortiz Nicolas, Smith Ryan
Department of Urology, University of Virginia, Charlottesville, VA, USA.
Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
Transl Androl Urol. 2024 Oct 31;13(10):2194-2200. doi: 10.21037/tau-24-329. Epub 2024 Oct 28.
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/mm 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.
背景：低强度冲击波疗法（LiSWT）是一种新兴的用于治疗勃起功能障碍（ED）的非侵入性恢复性疗法，已证明其有效性且不良事件较少。尽管LiSWT已被证明可改善ED男性的勃起功能，但很少有研究考察其长期疗效。我们展示了一项评估LiSWT后勃起功能的随机对照试验（RCT）的长期结果。 方法：弗吉尼亚大学共纳入30例基线期ED患者，随机分为LiSWT组或假治疗组。假治疗组患者在1个月时交叉治疗且不再设盲。初始试验完成后，纳入长期结局研究的患者被视为一个合并队列。使用Storz Duolith™设备，每周对患者进行两次治疗，连续治疗3周，向阴茎远端、阴茎根部和阴茎脚输送3000次能量为0.1 mJ/mm的冲击波。主要结局指标为从基线（治疗前3个月）至治疗后36个月男性性健康量表（SHIM）和勃起硬度评分（EHS）的变化。使用线性混合效应模型评估SHIM和EHS评分的变化。通过治疗满意度勃起功能障碍量表（EDITS）指数评估患者满意度。 结果：基线期SHIM平均评分为10.8±0.94。治疗后12个月、24个月和36个月评估时，SHIM平均评分分别为15.6±1.27（P<0.001）、15.0±1.14（P<0.001）和12.2±1.43（P=0.31）。基线期EHS平均评分为1.87±0.17。治疗后12个月、24个月和36个月评估时，EHS平均评分分别为2.70±0.24（P<0.001）、2.66±0.21（P<0.001）和2.29±0.26（P=0.10）。EDITS评分中位数[四分位间距（IQR）]为48.9（22.7，74.4），表明对LiSWT中度满意。未记录到不良事件。 结论：我们的分析表明，LiSWT治疗后不同人群的勃起功能长期持续改善。虽然受样本量限制，但结果表明，在最初2年勃起功能持续改善，1年时治疗效果达到峰值。治疗效果在2至3年之间似乎有所下降。 临床试验注册：ClinicalTrials.gov，NCT04434352。
Minerva Endocrinol (Torino). 2023-3
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