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

© The Canadian Journal of Urology TM : International Supplement, August 2020 48% (12/25) in the placebo group (p = 0.013, RR=0.29, 95% CI 0.09-0.87). However, while these studies have demonstrated positive findings in terms of pain relief, none reported significant improvements in penile curvature or plaque size. Furthermore, Chitale et al reported no significant changes in IIEF, pain reduction, curvature, and plaque size in their prospective randomized controlled double-blind trial comparing limited shock wave therapy to sham treatment in 36 PDmen (stable disease > 6months). 31 Given its limited utility in treating only pain symptoms, which often spontaneously resolve in the natural history of PD, along with the associated risks and adverse events (i.e. localized petechial bleeding/bruising, urethral bleeding or transient hematuria, minor ecchymosis, increased pain), providers ought to thoroughly discuss the risks, benefits, and cost of LiSWT. Further investigation is needed, with current AUA guidelines giving a conditional recommendation for its use to improve penile pain while recommending against its use for reduction of penile curvature or plaque size. 10 EMDA is an external energy therapy that involves using iontophoresis as a mechanism to transdermally deliver drug therapy to target tissues with minimal side effects. Greenfield et al performed a randomized, double-blind, placebo-controlled trial of 42 passive phase PDpatientswhich comparedEMDAverapamil to saline and found that therewas no statistically significant difference between the two treatment groups at 3months follow up. 32 Given poor evidence of efficacy, the AUA guidelines do not recommend EMDA with verapamil for treatment of PD. 10 However, scientific studies continue to explore various combination therapies with EMDA. In a prospective, randomized controlled study, Di Stasi et al looked at EMDA combination therapy with verapamil + dexamethasone. 33 After 6 weeks, the EMDA verapamil + dexamethasone study group demonstrated significant decreases in median plaque volume (824 mm to 348 mm) and in penile curvature (43° to 21°), whereas the control group demonstrated no significant changes. Additionally, the treatment group experienced significant permanent pain relief compared to transient pain relief in the control group. However, with only a single study and a small sample size, further randomized controlled studies with larger sample sizes are required before determining meaningful benefit. PTT is a therapy that works through a mechanical means and has been studied for use in both active and passive phases. Levine et al performed the first study which used the FastSize Penile Extender (Aliso Viejo, CA, USA) in 11 men (mean PD duration 29 months), 8 of whom previously failed non-surgical treatments. 34 The traction therapy involved using the device 2-8 hours per day for 6 months. After 6 months, all men experienced reduced curvature (mean reduction 22°) and increased stretched penile length (up to 2.5 cm). Additionally, mean IIEF increased from 44.6 to 55 and there was no change in penile sensation or new ED in the treatment group. In another study, Gontero et al investigated PTT using the Andropenis (Andromedical, Madrid, Spain) penile extender in 15 patients with PD for over 12 months, curvature < 50°, and fibrous plaque diagnosed on physical exam or ultrasound. 35 Tractionwas performed for 5-9 hours per day for a total of 6 months. While the study reported an increase in mean stretched and flaccid penis length after 6 months (1.3 cm and 0.83 cm respectively), only 6/15 patients experienced improvement in penile curvature with nonsignificant decrease from mean baseline of 31° to 27° after 6 months (p = 0.059). To explore the efficacy of PTT in the active phase, Martínez-Salamanca et al performed a nonrandomized prospective controlled trial comparing 55 active phase men who underwent PTT for 6 months to 41 active phase men who received no intervention. 36 Their results showed that PTT during the active phase significantly decreased mean curvature at 9 months (mean decrease 20°; p < 0.05), decreased pain (VAS score decrease from 5.5 to 2.5; p < 0.05), and improved erectile function, hardness, and ability to achieve penetration. Importantly, PTT was associated with sonographic plaque disappearance in 48% of patients and reduced the need for surgery in 40% of patients who would otherwise have been surgical candidates. While these studies demonstrated some positive results, the previously described regimens presented significant limitations. Patients may be reluctant to consider PTT due to the strict regimen with frequent and lengthy treatment times for 6 months, discomfort, and the presence of an apparatus on the penis. As a result, the novel RestoreX (PathRight Medical Inc., Plymouth, MN, USA) PTT device was developed and studied to determine whether this therapy regimen could be made more accessible and attractive for patients. 37 In their study, Ziegelmann et al performed a randomized, controlled, single-blind, intent to treat trial in men with PD, with a total of 110 men randomized 3:1 to the PTT group (30-90 minutes per day for 3 months) or control group (no therapy for 3 months). At 3 months, PTT using RestoreX demonstrated significant improvements over the control in penile length (1.5 versus 0 cm; p < 0.001), curvature (-11.7° versus 1.3°; p < 0.01), and erectile function (IIEF-Erectile Function domain 4.3 versus -0.7; p = 0.01) among those with ED. This study demonstrated safe and effective PTT using a novel 15 Peyronie’s disease: what do we know and how do we treat it?