intralesional injection of hyaluronic acid in patients affected with peyronie's disease: preliminary results from a prospective, multicenter, pilot study

Introduction: Hyaluronic acid has been shown to be efficacious in decreasing scar formation, inflammation, and oxidative stress. Aim: To assess the efficacy of intralesional injection of hyaluronic acid in patients affected by Peyronie's disease. Methods: In this prospective, single-arm, self-controlled, interventional, multicenter pilot study, 65 patients underwent a 10-week cycle of weekly intraplaque injections with hyaluronic acid (0.8% highly purified sodium salt hyaluronic acid 16 mg/2 mL; Sinovial, IBSA, Lodi, Italy). Patients were re-evaluated 2 months after the end of therapy. Main Outcome Measures: Plaque size (millimeters), penile curvature (degrees), International Index of Erectile Function (IIEF-5) score, visual analog scale (VAS) score for sexual satisfaction, and Patient's Global Impressions of Improvement (PGI-I) score. Results: Median age was 57 years (range = 23–70). At baseline, mean plaque size was 10 mm (range = 3–30 mm), mean penile curvature was 30° (range = 0°–50°), and mean IIEF-5 score was 20 (range = 0–25), with slight to moderate erectile dysfunction (IIEF score < 21) in 36 of 65 patients (55%). A median VAS score of 6 (range = 2–10) was found. Mean follow-up was 12 months (range = 6–24 months). Statistically significant post-treatment improvements were detected for plaque size (before treatment = 10 mm [3–30 mm], after treatment = 8 mm [1–30 mm], P < .0001), penile curvature (before treatment = 30° [0°–50°], after treatment = 20° [0°–40°], P < .0001), IIEF-5 score (before treatment = 20 [11–25], after treatment = 21 [15–25], P < .0001), and VAS score (before treatment = 6 [2–10], after treatment 8 [2–10], P < .0001). After treatment, the rate of patients with an IIEF score lower than 21 decreased from 55% (36 patients) to 40% (25 patients). Overall improvement on the PGI-I questionnaire was 69%. Conclusion: Intralesional treatment with hyaluronic acid can improve plaque size, penile curvature, and overall sexual satisfaction and seems preferably indicated in the early (active) phase of the disease. Furthermore, it is easy to perform and well tolerated.