Intracavernous platelet-rich plasma in PDE5 inhibitor non-responders with erectile dysfunction: A self-controlled prospective interventional study with intermediate-term follow-up

Objectives Erectile dysfunction (ED) is a prevalent, multifactorial condition for which phosphodiesterase type 5 inhibitors (PDE5is) are ineffective in up to one third of patients. Platelet-rich plasma (PRP), enriched in bioactive growth factors, is a candidate regenerative therapy. We aimed to evaluate the changes in erectile function and the safety associated with intracavernous PRP injections in men with moderate-to-severe ED who were PDE5 inhibitor non-responders.Patients and methods In this single-centre, self-controlled prospective interventional study conducted between January 2022 and January 2023, 100 men aged 35–70 years with an International Index of Erectile Function-5 (IIEF-5) score ≤ 17 received four intracavernous injections of autologous leukocyte-poor PRP (1 mL per corpus cavernosum) administered every two weeks. Each patient served as his own control, with pre-treatment values used as the reference for comparison. Patients were assessed at baseline and at 3, 6 and 12 months using the IIEF-5 score, visual analogue scale (VAS) for sexual satisfaction, and an erection-duration diary. Safety was monitored at each visit. The study is reported in accordance with the STROBE statement.Results At 3 months, 80% of participants were responders (defined as a ≥ 4-point increase in IIEF-5), with a mean increase of 5.2 points (95% CI 4.8–5.6), largely maintained at 12 months in 70% of participants (mean increase 4.3 points, 95% CI 3.9–4.7). Mean erection duration increased from 3.1 min (95% CI 2.8–3.4) at baseline to 6.8 min (95% CI 6.4–7.2) at 3 months (repeated-measures ANOVA, p < 0.001). Younger patients (<50 years), those without cardiovascular comorbidities and those with moderate (vs severe) baseline ED achieved the largest gains. No serious adverse events occurred; transient injection-site pain was reported in 10% of cases.Conclusions In this self-controlled prospective interventional study, intracavernous PRP was associated with clinically relevant and durable improvements in erectile function and an excellent safety profile, particularly in younger men without major comorbidities. As the study lacked a control group, these findings represent associations rather than proof of efficacy and warrant confirmation in randomised, placebo-controlled trials.