INVESTIGATIVE UROLOGY

Liposomal recombinant human superoxide dismutase for the treatment of Peyronie’s disease: a randomized placebo-controlled double-blind prospective clinical study
Riedl CR, Sternig P, Galle G, Langmann F, Vcelar B, Vorauer K, Wagner A, Katinger H, Pfluger H
Department of Urology, Thermenklinikum Baden, Austria
Eur Urol. 2005; 48: 656-6

• Objective: To demonstrate the efficacy and safety of a topical gel containing liposomally encapsulated recombinant human Superoxide Dismutase (lrhSOD) in the treatment of painful Peyronie’s Disease. The theoretical background is that lrhSOD, by scavenging of free oxygen radicals, might interrupt inflammatory cascades and thereby limit further disease progression.
• Methods: In a placebo-controlled randomized clinical trial, 39 patients with Peyronie’s Disease and significant pain symptoms were treated with lrhSOD or placebo for a 4 week period. At this time, statistical evaluation of pain resolution was performed as primary study endpoint. Patients then were continued in a cross-over study design to ensure a total of 8 weeks of lrhSOD therapy for all study participants. Pain, plaque and curvature assessment was performed at study entry and every 4 weeks until week 12.
• Results: LrhSOD treatment resulted in a statistically significant reduction of pain (p=0.017) compared to placebo already after 4 weeks. At week 12 pain was significantly reduced in 89% of patients who all had received 8 weeks of lrhSOD therapy at that time. Response to other disease parameters was assessed at week 12: plaque size was reduced in 47% of patients, as was plaque consistence in 38%. Penile curvature was improved at 5-30 degrees in 23% of patients. The expected spontaneous disease progression rate of up to 40%, as reported by several investigators, was significantly reduced to <10% under lrhSOD therapy, and patients satisfaction was high, also consequent to the lack of therapy-related side effects observed in the present study.
• Conclusion: LrhSOD is an easily administrable, safe and effective local therapeutic for the painful phase of Peyronie’s Disease.
  
  
• Editorial Comment
  Around 4 years ago, the authors in an uncontrolled phase-2 study, treated 20 Peyronie’s disease patients with a gel containing lrhSOD (1.5 mg/g). The study included patients with penile deviation greater than 45 degrees or plaque calcifications of greater than 5 mm. The authors found 100% pain relief and plaque size reduction in 56% of patients after a maximum of 6 weeks of lrhSOD therapy.
  In the present placebo controlled study, the authors confirmed a statistical significant reduction of pain symptoms when compared to placebo, resulting in an overall efficacy of more than 80% after 8 weeks of therapy.
  As the authors state, conservative therapies for Peyronie’s disease are symptom-directed (analgesic and preventive against disease progression), while correction of deviation is surgical. The liposomally encapsulated recombinant human SOD is a good alternative because shows good efficacy when administered in patients with painful Peyronie’s disease lesions. Also, the expected rate of spontaneous disease progression would be reduced, as well as morbidity and the need for future surgery. Probably, the association of clinical and minimally invasive therapy (such as ESWL) would be the future first line treatment for Peyronie’s disease.

Dr. Francisco J.B. Sampaio
Full-Professor and Chair, Urogenital Research Unit
State University of Rio de Janeiro
Rio de Janeiro, Brazil