Study design, materials and methods
A total of 207 men with ED were enrolled and randomized into two groups. Group 1 (n = 100) received ESWT (Dornier Aries) applied to the penile shaft twice weekly for 6 weeks. The mean age was 43.9 years (20–69), and the mean duration of ED was 3.4 years (0.5–4).
Group 2 (n = 107) underwent a combined protocol: two treatment sessions per week for 6 weeks. In each cycle, Session 1 consisted of ESWT followed by PRP injections into the penis, after which PRP activation was performed with ESWT; Session 2 included ESWT alone. All participants were assessed at baseline and after 60 days using the International Index of Erectile Function-5 (IIEF-5), Erectile Hardness Score (EHS), Sexual Encounter Profile (SEP), Global Assessment Question (GAQ), and color Doppler penile duplex ultrasonography (D-PDU). Results are presented as median (IQR). The study was approved by the Ethics Committee of the RUDN University Medical Institute.
Results
In Group 1, mean IIEF-5 increased from 15.4 (9.0–18.5) to 18.5 (14.2–22.1) (p < 0.001) at 60 days. SEP improved from 2.0 (1–3) to 3 (2–4) (p < 0.001). EHS rose from 1.5 (1–2) to 2.9 (2.6–3) (p < 0.001). On D-PDU, peak systolic velocity (PSV) increased from 18.9 cm/s (12.7–26.2) to 25.9 cm/s (19.8–33.6) (p < 0.001), and resistive index (RI) improved from 0.72 (0.7–0.9) to 0.89 (0.78–0.96) (p < 0.05).
Sixty patients (60 %) reported subjective improvement according to GAQ at follow-up. In Group 2, baseline IIEF-5 was 13.5 (11–17) and increased to 20.6 (16.1–23) (p < 0.001) after 60 days. SEP improved from 2 (1–3) to 3.5 (3–4) (p < 0.001). EHS rose from 2 (1–2) to 3 (3–4) (p < 0.001). Median PSV increased from 16.9 cm/s (14.2–26.8) to 27.9 cm/s (24.8–37.9) (p < 0.001), and RI improved from 0.70 (0.64–1) to 0.96 (0.85–1) (p < 0.05). According to GAQ, 85 patients (79.4 %) reported positive treatment outcomes. Intergroup comparison demonstrated significantly greater improvement in erectile function in the combination-therapy group (p < 0.05) across IIEF-5, SEP, EHS, and D-PDU parameters.
Interpretation of results
Both ESWT alone and in combination with PRP were well tolerated and effective in men with ED. The combined PRP + ESWT protocol produced superior improvements in erectile function, penile hemodynamics, and patient satisfaction, suggesting it may represent a more promising therapeutic approach.