Comparison of Intralesional Hyaluronic Acid vs. Verapamil for the Treatment of Acute Phase Peyronie's Disease: A Prospective, Open-Label Non-Randomized Clinical Study

Abstract

Purpose: To compare the efficacy and safety of intralesional hyaluronic acid (HA) as compared with verapamil injection in patients with Peyronie's disease (PD). Materials and Methods: Between January 2015 and December 2018, men in PD acute phase were prospectively recruited. This open-label, prospective study included 2 different protocols. Group A: 8-week cycle of weekly intraplaque injections with HA; Group B: 8-week cycle of weekly intraplaque injections with verapamil. Penile curvature, plaque size, International Index of Erectile Function (IIEF)-15 score and visual analogue scale (VAS) were assessed at baseline and after 3 months. Results: Two-hundred forty-four patients were enrolled. Of these, 125 received intralesional HA (Group A), 119 received intralesional verapamil (Group B). At enrollment, median age was 56.0 years (interquartile range [IQR]=47.0-63.0 years), median curvature 35.0° (IQR=25.0°-45.0°), median IIEF-15 score 19.0 (IQR=16.0-23.0), median VAS 4.0 (IQR=4.0-5.0). Median difference for IIEF-15 was 1.0 (95% confidence interval [CI]=1.12-1.94) in Group A and 0.0 (95% CI=-0.04-0.14) in Group B (p<0.05) and median difference for VAS score was-4.0 (95% CI=-4.11-3.65) in Group A and-1.0 (95% CI=-0.50-2.01) in Group B (p<0.05). Plaque size decreased by-1.50 mm (IQR=1.60-2.10 mm) in Group A and-1.20 in Group B (p=0.10), while penile curvature decreased by-9.50° (IQR=4.50°-13.00°) in group A and-4.50 (IQR=2.50-7.50) in Group B (p<0.01). Conclusions: Intralesional HA injections could represent a reliable treatment option for the conservative management of patients with acute phase of PD.

Clinical use of hyaluronic acid in andrology: A review

“…The study was limited by the absence of a placebo group, only 3 months of follow-up, and the subjective variables associated with the plaque measurement in the 11 Italian centers enrolled. Similar results were published by Cocci et al28 in a prospective, nonrandomized study, comparing two groups of patients affected by PD and treated respectively with a course of HA infiltrations (0.8% highly purified sodium salt HA 16 mg/2 ml) and with Verapamil 10 mg. The IIEF, plaque size, degree of curvature calculated with a goniometer at maximum penile rigidity were used as outcome parameters.…”

The Natural History of Peyronie's Disease

“…In the early phase of the disturbance, patient may present with penile pain, especially during erection and sexual intercourse, penile curvature, or simply penile deformation (shortening or narrowing) without clearly palpable plaque. It should be kept in mind that most patients present with a palpable plaque, but some are unaware of it [ 15 ]. In some cases, non-palpable isolated septal plaques without deformity of the penis may be present.…”

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

“…Zucchi et al [ 5 ] used 10 weeks treatment duration, Favilla et al [ 6 ] used 12 weeks, while we used 6 weeks treatment schedule in our study. In the 2020, Cocci et al [ 9 ] reported a better outcome in terms of VAS score reduction, IIEF-5 improvement and reduction of penile curvature in patients treated with HA when compared with intralesional verapamil. We believe that the efficacy reported with our shorter treatment schedule is due to the addition of the oral administration of HA.…”