Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL.
Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL.
Urology. 2023 Aug;178:83-90. doi: 10.1016/j.urology.2023.01.061. Epub 2023 Apr 17.
To identify clinics offering off-label therapies for erectile dysfunction (ED) and Peyronie's disease (Pyd) including stem cell, platelet-rich plasma (PRP), and shockwave therapy and to determine the transparency they provided to patients inquiring about these treatment modalities.
Clinics were identified in different regions in the US using a systematic search on online website directories and were approached by asking a series of standardized questions regarding the cost of treatment, duration of therapy, the medical staff involved, and patient outcome data. A total of 26 clinics were surveyed for stem cell therapy, 26 for PRP treatment, and 27 for shockwave therapy.
Of the 79 clinics contacted, 93.7% provided some answers to the questions we asked, with a majority offering treatments for both ED and Pyd. The cost of treatment varied widely between clinics. The average cost per stem cell therapy injection was $5291, PRP per injection was $1336, and shockwave therapy per session was $413. A physician was involved in 67% of treatments, and only 6 of 79 clinics reported that a urologist was involved. Over 75% of the clinics reported patient satisfaction following treatment. Durability of benefits to patients ranged from months to years according to the clinics' reports.
Our data not only demonstrate the widespread use of off-label therapies for ED and PyD across the United States but also the lack of scientific data to support the claims made to patients. This study highlights the need for more oversight and standardization in novel regenerative therapies for ED and PyD.
确定提供非标签治疗勃起功能障碍(ED)和 Peyronie 病(Pyd)的诊所,包括干细胞、富含血小板的血浆(PRP)和冲击波治疗,并确定它们向询问这些治疗方式的患者提供的透明度。
使用系统搜索在线网站目录在美国不同地区确定诊所,并通过询问一系列关于治疗费用、治疗持续时间、参与的医务人员以及患者结果数据的标准化问题来接近这些诊所。共调查了 26 家干细胞治疗诊所、26 家 PRP 治疗诊所和 27 家冲击波治疗诊所。
在所联系的 79 家诊所中,93.7%对我们提出的问题提供了一些答案,其中大多数提供 ED 和 Pyd 的治疗。治疗费用在诊所之间差异很大。每个干细胞治疗注射的平均费用为 5291 美元,PRP 每次注射的费用为 1336 美元,冲击波治疗每次疗程的费用为 413 美元。67%的治疗涉及医生,只有 79 家诊所中的 6 家报告泌尿科医生参与。超过 75%的诊所报告称,患者在治疗后感到满意。根据诊所的报告,患者受益的持久性从几个月到几年不等。
我们的数据不仅表明美国广泛使用非标签治疗 ED 和 PyD,而且缺乏支持向患者提出的主张的科学数据。本研究强调需要对 ED 和 PyD 的新型再生治疗进行更多的监督和标准化。