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

The aim of this study was to compare the effect of combined oral administration and intralesional injection of hyaluronic acid (HA) with intralesional injections alone, in patients with early onset of Peyronie's disease (PD).

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 received 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.

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).

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.

The world journal of men's health. 2020 Aug 14 [Epub ahead of print]

Tommaso Cai, Daniele Tiscione, Vincenzo Favilla, Marco Puglisi, Fabrizio Palumbo, Alessandro Zucchi, Gianni Malossini, Alessandro Palmieri, Truls E Bjerklund Johansen

Department of Urology, Santa Chiara Regional Hospital, Trento, Italy. ., Department of Urology, Santa Chiara Regional Hospital, Trento, Italy., Department of Urology, University of Catania, Catania, Italy., Department of Urology, San Giacomo Hospital, Monopoli, Italy., Department of Urology, University of Perugia, Perugia, Italy., Department of Urology, University of Naples Federico II, Naples, Italy., Department of Urology, Oslo University Hospital, Oslo, Norway.