Intralesional Injection of Hyaluronic Acid in Patients Affected With Peyronie's Disease: Preliminary Results From a Prospective, Multicenter, Pilot Study

Abstract

IntroductionHyaluronic acid has been shown to be efficacious in decreasing scar formation, inflammation, and oxidative stress.AimTo assess the efficacy of intralesional injection of hyaluronic acid in patients affected by Peyronie's disease.MethodsIn this prospective, single-arm, self-controlled, interventional, multicenter pilot study, 65 patients underwent a 10-week cycle of weekly intraplaque injections with hyaluronic acid (0.8% highly purified sodium salt hyaluronic acid 16 mg/2 mL; Sinovial, IBSA, Lodi, Italy). Patients were re-evaluated 2 months after the end of therapy.Main Outcome MeasuresPlaque size (millimeters), penile curvature (degrees), International Index of Erectile Function (IIEF-5) score, visual analog scale (VAS) score for sexual satisfaction, and Patient's Global Impressions of Improvement (PGI-I) score.ResultsMedian age was 57 years (range = 23–70). At baseline, mean plaque size was 10 mm (range = 3–30 mm), mean penile curvature was 30° (range = 0°–50°), and mean IIEF-5 score was 20 (range = 0–25), with slight to moderate erectile dysfunction (IIEF score < 21) in 36 of 65 patients (55%). A median VAS score of 6 (range = 2–10) was found. Mean follow-up was 12 months (range = 6–24 months). Statistically significant post-treatment improvements were detected for plaque size (before treatment = 10 mm [3–30 mm], after treatment = 8 mm [1–30 mm], P < .0001), penile curvature (before treatment = 30° [0°–50°], after treatment = 20° [0°–40°], P < .0001), IIEF-5 score (before treatment = 20 [11–25], after treatment = 21 [15–25], P < .0001), and VAS score (before treatment = 6 [2–10], after treatment 8 [2–10], P < .0001). After treatment, the rate of patients with an IIEF score lower than 21 decreased from 55% (36 patients) to 40% (25 patients). Overall improvement on the PGI-I questionnaire was 69%.ConclusionIntralesional treatment with hyaluronic acid can improve plaque size, penile curvature, and overall sexual satisfaction and seems preferably indicated in the early (active) phase of the disease. Furthermore, it is easy to perform and well tolerated.

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

“…In December 2013 collagenase clostridium histolyticum (CCh/Xiaflex) was approved by the US Food and Drug Administration (FDA) for treatment of Peyronie's disease. Intralesional treatment with HA decreased plaqued size and penile curvature and improved IIEF in a prospective, single arm, self-controlled, interventional, multicentre pilot study on 65 patients (Zucchi et al, 2016). However, this compound has been found to produce the potential occurrence of mild to severe adverse events, including penile ecchymosis, swelling, pain, and corporal rupture (Gelbard et al, 2013).…”

“…These therapeutic options include: oral treatment (potassium para-aminobenzoate, Potaba), vitamin E, colchicine, tamoxifen, carnitine, pentoxifylline, phosphodiesterase type 5 inhibitors); intralesional treatment [steroids, verapamil, collagenase clostridium histolyticum (CCh), interferons]; and topical treatment [extracorporeal shock wave therapy (ESWT), iontophoresis, traction devices and vacuum devices] (Hauck et al, 2006;Safarinejad et al, 2010;Hatzimouratidis et al, 2012;Gelbard et al, 2013;Favilla et al, 2014;Levine et al, 2015;Nehra et al, 2015). Recent prospective, multicenter, pilot study assessing the efficacy of hyaluronic acid (HA) as intralesional treatment for patients with PD showed encouraging preliminary results for improvement of plaque size, penile curvature, and overall sexual satisfaction (Zucchi et al, 2016) and similar results are reported in other study (Gennaro et al, 2015). For this reason, the intralesional therapy with verapamil, for reduced side effects and lower costs, remains the most widely used especially in Europe.…”

Evaluation of the benefit of using a combination of autologous platelet rich-plasma and hyaluronic acid for the treatment of Peyronie’s disease

“…Contrary to CCH, which main aim is to destroy the plaque, PRP combined with HA is expected to restore normal tissue after digging of small tunnels into TA's fibrotic tissue with a needle (see below). HA alone has been shown to be active on PD in a placebo-controlled study [8]. Preliminary data seems to indicate that a combination of PRP and HA provides better outcomes than HA alone for the treatment of gonarthrosis [19,20] and wound defects [21,22].…”

“…More recently, Hyaluronic Acid (HA) (7) and Botulinum toxin [8] have also been proposed with the purpose of counteracting tunica fibrosis, the final issue of the pathological process of PD, before the deposit of calcifications [4]. We hypothesized that regenerative medicine could help stop the process and restore function.…”

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.…”