Low-intensity Extracorporeal Shock Waves for Treatment of Erectile Dysfunction in Patients Not Responding to Phosphodiesterase Type 5 Inhibitors, Its Durability, and Factors That May Influence the Outcome: A Clinical Trial
A. Hamidi Madani, Mahmoud Shabanipour, Mohammad Hamidi Madani, Gh R Mokhtari, E. Kazemnezhad, A. Karimi Rouzbahani, Mahshid Abhari Khoshdel
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引用次数: 0
Abstract
Background: Non-invasive treatments, such as low-intensity extracorporeal shock waves treatment (Li-ESWT), can be a safe and effective alternative for patients with erectile dysfunction (ED) who are resistant to phosphodiesterase type 5 inhibitors (PDE5Is). Objectives: This clinical trial study aimed to evaluate the effect of Li-ESWT on ED in non-responders to PDE5Is, its durability, and factors predicting its success. Methods: This study was conducted on 128 patients with ED who were resistant to PDE5Is. Before any intervention, written informed consent was obtained, demographic characteristics were collected, and the severity of the ED score was determined using the international index of erectile function (IIEF). Patients were treated with Li-ESWT, and ED severity was remeasured by the IIEF scale at the end of the intervention, three months, and six months after the intervention. The data were analyzed by chi-square, repeated measure ANOVA, Bonferroni post hoc, and binary logistic regression tests. Results: A total of 128 patients with ED who had not responded to PDE5Is, with a mean age of 58.35 ± 8.28 and an average ED of 3.41 ± 1.78 years, were included. At the end of the intervention, the IIEF score significantly increased. Moreover, this score was significantly higher three months and six months after the intervention. Three and six months later, the IIEF score decreased significantly. However, the score was significantly higher all three times than before the intervention. Being younger than 60 years, having an ED duration of fewer than three years, being non-smoking, being non-diabetic, and having no lower urinary tract symptoms (LUTS) were the most prominent predictors of a successful ED treatment. Conclusions: Low-intensity extracorporeal shock waves treatment is a safe and effective method for short and long-term treatment of ED patients. Identifying predicting factors can be beneficial for urologists in selecting suitable patients and avoiding the overtreatment of those who are not suitable candidates.
背景:低强度体外冲击波治疗(Li-ESWT)等非侵入性治疗方法,对于对磷酸二酯酶 5 型抑制剂(PDE5Is)耐药的勃起功能障碍(ED)患者来说,是一种安全有效的替代疗法。研究目的这项临床试验研究旨在评估 Li-ESWT 对 PDE5Is 无应答者的 ED 效果、其持久性以及预测其成功的因素。研究方法研究对象为 128 名对 PDE5Is 耐药的 ED 患者。在采取任何干预措施之前,均已获得患者的书面知情同意,收集了患者的人口统计学特征,并使用国际勃起功能指数(IIEF)确定了患者的 ED 严重程度。患者接受了Li-ESWT治疗,并在干预结束、三个月和六个月后使用IIEF量表重新测量了ED严重程度。数据采用卡方检验、重复测量方差分析、Bonferroni post hoc 和二元逻辑回归检验进行分析。结果共纳入128名对PDE5Is无效的ED患者,平均年龄(58.35±8.28)岁,平均ED时间(3.41±1.78)年。干预结束后,IIEF评分明显提高。此外,干预三个月和六个月后,IIEF 分数也明显提高。三个月和六个月后,IIEF 分数明显下降。然而,这三次的得分都明显高于干预前。年龄小于 60 岁、ED 持续时间少于三年、不吸烟、无糖尿病、无下尿路症状(LUTS)是预测 ED 治疗成功的最主要因素。结论是低强度体外冲击波治疗是一种安全有效的短期和长期治疗 ED 患者的方法。找出预测因素有助于泌尿科医生选择合适的患者,避免对不合适的患者进行过度治疗。