Saltzman Russell G, Golan Roei, Masterson Thomas A, Sathe Aditya, Ramasamy Ranjith
Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
Florida State University College of Medicine, Tallahassee, FL, USA.
Int J Impot Res. 2023 Dec;35(8):720-724. doi: 10.1038/s41443-022-00610-3. Epub 2022 Sep 6.
Given the lack of regulatory approval for restorative therapies for the treatment of erectile dysfunction, we hypothesized that clinical trials would vary in methodology and endpoint measurements. Our objective was to analyze methodological approaches and outcome measures of clinical trials evaluating restorative therapies for erectile dysfunction. Data was extracted from clinicaltrials.gov on trials which contained the keywords "erectile dysfunction". We evaluated trials initiated between 2004 and 2021 which listed a restorative therapy intervention. We identified 95 trials investigating energy-based/shockwave therapies (60/95), stem cell therapies (25/95), platelet-based therapies (6/95), and others (4/95). Only 41.1% of the trials evaluated safety. The most common efficacy endpoint was International Index of Erectile Function and Sexual Health Inventory for Men, and only 29.5% utilized penile Doppler. Thirty (31.6%) trials had been completed yet only 3 (3.2%) have published results. We found substantial heterogeneity in methodological approach in the trials. Subjective measures of erectile function were commonly reported, but definitions of inclusion criteria and objective outcome measures were inconsistent. These results provide a basis for the design of future clinical trials to improve the quality of trial data and aid in the development of standardized criteria for erectile dysfunction clinical trials.
鉴于用于治疗勃起功能障碍的恢复性疗法缺乏监管批准，我们推测临床试验在方法和终点测量方面会有所不同。我们的目的是分析评估勃起功能障碍恢复性疗法的临床试验的方法学方法和结局指标。从clinicaltrials.gov上提取了包含关键词“勃起功能障碍”的试验数据。我们评估了2004年至2021年期间启动的列出恢复性疗法干预措施的试验。我们确定了95项研究基于能量/冲击波疗法（60/95）、干细胞疗法（25/95）、基于血小板的疗法（6/95）和其他疗法（4/95）的试验。只有41.1%的试验评估了安全性。最常见的疗效终点是国际勃起功能指数和男性性健康量表，只有29.5%的试验使用了阴茎多普勒检查。30项（31.6%）试验已完成，但只有3项（3.2%）发表了结果。我们发现试验在方法学方法上存在很大异质性。勃起功能的主观测量方法普遍被报告，但纳入标准的定义和客观结局指标并不一致。这些结果为未来临床试验的设计提供了基础，以提高试验数据的质量，并有助于制定勃起功能障碍临床试验的标准化标准。
