World J Mens Health.  2021 Jul;39(3):526-532. 10.5534/wjmh.200048.

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

• Cai T
• Tiscione D
• Favilla V
• Puglisi M
• Palumbo F
• Zucchi A
• Malossini G
• Palmieri A
• Johansen TEB

• KMID: 2516718
• DOI: http://doi.org/10.5534/wjmh.200048

Abstract

Purpose
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).
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 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.
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
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.

Keyword

Hyaluronic acid; Injections intralesional; International index of erectile function-5; Penile induration; Quality of life; Therapeutics