DefinePK

Abstract

Background: Erectile dysfunction (ED) is a prevalent complication among diabetic men, often refractory to conventional pharmacologic therapies due to vascular and neural impairments. Platelet lysate (PL), a growth factor-rich biological derivative, has emerged as a potential regenerative therapy for vasculogenic ED. However, data on its clinical efficacy and safety remain limited, particularly in resource-constrained settings. Objective: To evaluate the efficacy and safety of intracavernous PL injections in diabetic men with moderate to severe ED. Study Design: Prospective interventional study. Setting: The study was conducted at the Institute of Kidney Diseases, Peshawar, Pakistan. Duration of Study: February 18, 2024, to February 18, 2025. Methods: A total of 72 diabetic men aged 40–65 years with moderate to severe ED (International Index of Erectile Function-5 [IIEF-5] score: 5–11) were enrolled. Each participant received three intracavernous injections of autologous PL at two-week intervals. Erectile function was assessed using the IIEF-5 questionnaire at baseline and 12 weeks post-treatment. Adverse events were monitored to evaluate treatment safety. Statistical analysis was performed using SPSS v26, with a p-value of <0.05 considered statistically significant. Results: The mean IIEF-5 score significantly improved from 8.6 ± 1.9 at baseline to 15.3 ± 2.8 at 12 weeks (p < 0.001). Improvements were observed in all erectile function domains, including erection confidence, penetration ability, and overall satisfaction. Clinically significant improvement was noted in 86.8% of patients with moderate ED and 73.5% of those with severe ED. The treatment was well tolerated, with mild, transient adverse effects, including penile pain (12.5%) and local bruising (8.3%). No cases of fibrosis, priapism, or infection were reported. Conclusion: Intracavernous PL injections demonstrated significant efficacy and safety in diabetic men with ED, leading to substantial improvements in erectile function and patient satisfaction. These findings highlight PL therapy as a promising alternative for ED management, particularly in patients unresponsive to conventional treatments and in resource-limited healthcare settings. Further large-scale studies are recommended to validate these results.