Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double‐blinded, randomized study

Abstract

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I.

Recent advances in managing Peyronie’s disease

“…The comparative study by Favilla et al described previously in this paper also showed advantageous outcomes of HA when compared to verapamil therapy 47 .…”

A snapshot of intralesional verapamil injection in the treatment of Peyronie's disease today

“…A final consideration is the comparative efficacy of IVI and other experimental therapies that have shown promise in the treatment of PD, including interferon alpha‐2b (Hellstrom et al, ) and hyaluronic acid (Zucchi et al, ). Studies have concluded that these treatments are comparatively better than verapamil in the improvement of certain outcomes (Favilla et al, ; Russo et al, , ). However, verapamil has a clear benefit over the first of these treatments: interferon alpha‐2b injection is associated with considerable side effects that IVI is not associated with (Wegner, Andresen, Knispel, & Miller, ).…”

2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature

“…Two retrospective studies and a more recent prospective study have shown a reduction in penile plaque size and curvature, as well as improved penile rigidity. [52][53][54] Botulinum toxin has been shown to reduce fibrosis and scarring. A single study evaluated botulinum toxin A as a treatment for PD and has shown a positive response for safety and improvement in penile curvature, while data from further investigations is pending.…”