Oral Administration and Intralesional Injection of Hyaluronic Acid Versus Intralesional Injection Alone in Peyronie’s Disease: Results from a Phase III Study

• Main Authors: Tommaso Cai, Daniele Tiscione, Vincenzo Favilla, Marco Puglisi, Fabrizio Palumbo, Alessandro Zucchi, Gianni Malossini, Alessandro Palmieri, Truls E. Bjerklund Johansen
• Format: Article
• Language: English
• Published: Korean Society for Sexual Medicine and Andrology 2021-07-01
• Series: The World Journal of Men's Health
• Subjects: hyaluronic acid; injections intralesional; international index of erectile function-5; penile induration; quality of life; therapeutics
• ISSN: 2287-4208; 2287-4690

Purpose: The aim of this study was to compare the effect of combined oral administration and intralesional injection of hyal-uronic acid (HA) with intralesional injections alone, in patients with early onset of Peyronie’s disease (PD). Materials and Methods:Materials and Methods: For this prospective, randomized phase III clinical trial we included patients with recent diagnosis of PD. Eighty-one patients were randomized into two groups. Group A consisted of 41 patients receiving oral administration of HA in combination with weekly intralesional injection of HA for 6 weeks. Group B consisted of 40 patients group B who re-ceived weekly intralesional injections of HA for 6 weeks, only. The main outcome measures were the changes from baseline to the end of therapy after three months in penile curvature (°) and changes in the international index of erectile function (IIEF-5) score and patient’s global impressions of improvement (PGI-I) score. Results:Results: Group A had a significantly larger reduction in penile curvature as compared with group B (Group A: -7.8°, Group B: -4.1° [p<0.001]). Group A also showed a higher improvement in IIEF-5 and PGI-I scores in comparison with Group B (Group A:+4 IIEF-5, Group B: +2 IIEF-5 [p<0.001]; Group A: 3 PGI-I, Group B: 1 PGI-I, [p<0.001]). At three months both groups had a significant reduction of penile curvature from baseline (p<0.001). Conclusions:Conclusions: Oral administration combined with intralesional treatment with HA shows greater efficacy to improve penile curvature and overall sexual satisfaction in comparison with intralesional HA treatment alone.