3rd Annual Jefferson Urology Symposium: Men’s Health Forum

© The Canadian Journal of Urology TM : International Supplement, August 2020 adverse events including sinusitis, flu-like symptoms, and minor penile swelling. These adverse events tend to be short in duration (< 48 hours) and may be managed effectively with over-the-counter NSAIDs. Interferon- α 2b has been studied for use in both active and passive phases. In a randomized prospective study, Inal et al showed in 30 men (early stage PD) that penile pain resolved after 6 months in more patients who were administered interferon- α 2b alone (71%) or interferon- α 2b + vitamin E (83.3%) compared to vitamin E alone (50%). 22 However, the study showed no statistically significant changes in both objective and subjective parameters. Furthermore, the study’s sample size was small (10 per group) and there was no true placebo group. Current data is limited for use in treating PD during the active phase and more studies are required. To assess the safety and efficacy of interferon- α 2b during the passive phase, Hellstrom et al performed a single-blind, multicenter, placebo controlled, parallel study in a total of 117 consecutive PD patients. 23 Injections were administered biweekly for 12 weeks with the control group receiving 10 mL of saline and the treatment arm receiving 5x10 6 U interferon- α 2b. Interferon- α 2b demonstrated significantly greater improvements compared to placebo in mean penile curvature (-13.5° versus -4.5°; p< 0.01), meanplaque size (-2.6 cm 2 versus -0.9 cm 2 ; p < 0.001), and mean plaque density assessed from questionnaires graded between 0 to 3 (-0.77 versus -0.23; p < 0.05). Interestingly, both the control group of this study as well as the IMPRESS trials demonstrated improvements at follow up, suggesting that the mechanical disruption performed by the needle upon injection may in and of itself assist plaque breakdown. In a separate study, Trost et al retrospectively analyzed 127 men (median history of PD of 2.0 years) treated with interferon- α 2b and found that 54% responded to therapy with an overall mean improvement of 9.0° (p < 0.001). 24 These studies suggest that interferon- α 2bmay be administered to PDpatients, with stronger data demonstrating its utility during the passive phase which is reflected in the current AUA guidelines. 10 Verapamil works as a calcium channel blocker and increases collagenase activity. Adverse events may include hypotension, headache, penile bruising, dizziness, nausea, and pain at the injection site. The first published study exploring its use as an intralesional injection was performed by Levine et al in 1994 and later updated in 2002. 25,26 The authors published their experience with verapamil in 156 men during the passive phase (mean disease duration 17.7 months) with 140 patients completing treatment (10mg biweekly injections over 6months). Of the 140 patients, 60%had an objectivelymeasured decrease in curvature (mean reduction 30°) with 62% reporting subjective improvement during follow up (mean 30.4 months). Positive results have also been demonstrated for use during the active phase. Arena et al showed in a study of 39 patients that 50%of those treated during the active phase experienced curvature improvement, compared to only 10.2% in the passive phase patient group. 27 These results suggest that verapamil may be more effective as an active phase treatment. Nevertheless, there have been no published studies of verapamil with placebo-controlled trials. Therefore, there is weak evidence demonstrating its efficacy and use. Due to this reason, it remains a conditional recommendation in treatment guidelines. 10 External therapies External energy therapies include penile low-intensity shockwave therapy (LiSWT), electromotive drug administration (EMDA) or iontophoresis, and penile traction therapy (PTT). AUA guidelines suggest that LiSWT may play a role during the active phase for pain management. 10 Palmieri et al performed a prospective, double-blind, placebo-controlled clinical trial which randomized PD patients (≤ 12 months) to receive either LiSWT (n = 50) or placebo (n = 50). 28 The study showed that at 24 weeks follow up, mean pain scores on a visual analog scale decreased more from baseline in the LiSWT group (5.5 to 0.46) than in the placebo/sham group (5.2 to 2.7). In a separate study, Palmieri et al conducted a prospective, randomized, controlled clinical trial comparing LiSWT alone to combination LiSWT + tadalafil 5 mg for management of patients with PD (< 12 months) and ED. 29 At 12 weeks followup, mean visual analog scale score, mean IIEF, and mean quality of life score were significantly improved in both groups while mean plaque size and mean curvature were unchanged. Importantly, at 24 weeks there was a significantly higher mean IIEF and mean quality of life score in patients that received LiSWT + tadalafil, suggesting its potential use in the conservative management of patients with PD and ED during the active phase. Hatzichristodoulou et al replicated these findings of pain relief during passive phase treatment in a placebo-controlled, prospective, randomized, single-blind study. 30 Their study demonstrated a greater decrease in mean pain scores on a VAS in the LiSWT group (4 to 1.5) compared to placebo/sham (4 to 3). Additionally, a subgroup analysis of the 45 patients who experienced pain at baseline showed that 85% (17/20) of patients in the LiSWT group reported pain decrease compared to only Chung et al. 14