The following is a summary of “Variability in the methodology of erectile dysfunction regenerative therapy trials on ClinicalTrials.gov,” published in the May 2024 issue of Urology by Gutierrez et al.
Researchers reviewed interventional trials on ClinicalTrials.gov using keywords like “erectile dysfunction,” “shockwave,” “platelet-rich plasma,” “stem cell,” “regenerative,” and “restorative.” The study group compared inclusion/exclusion criteria and primary/secondary outcomes across trials focusing on extracorporeal shockwave therapy (ESWT), platelet-rich plasma and stem cell injections (PRP/SC), and other regenerative therapies (ORT).
Among the 92 trials analyzed, the International Index of Erectile Function (IIEF) score was the most common primary outcome (72%), prominently featured in ESWT trials compared to PRP/SC or ORT trials (89% vs. 44% and 58%, respectively, p<.001). Safety and tolerability were primary outcomes in 44% of PRP/SC trials and 25% of ORT trials, but not in ESWT trials (p<.001). ESWT trials frequently included criteria related to sexual or romantic relationships and excluded patients undergoing cancer treatment, distinctions less common in PRP/SC and ORT trials.
Considerable variability exists in the inclusion/exclusion criteria and outcome measures across ED regenerative therapy trials. ESWT trials prioritize functional outcomes like the IIEF score and enforce stringent eligibility criteria, suggesting a focus on robust and outcome-driven research. In contrast, PRP/SC and ORT trials more often prioritize safety and tolerability, reflecting the experimental nature of these treatments. This diversity complicates direct comparisons among different ED regenerative therapies and underscores the need for standardized methodologies to advance evidence-based practice in this field.
Source: sciencedirect.com/science/article/abs/pii/S0090429524003704
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