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Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective clinical study.
Eur Urol. 2005 Oct; 48(4):656-61.EU

Abstract

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.

Authors+Show Affiliations

Department of Urology, Thermenklinikum Baden, Austria, Wimmergasse 19, 2500 Baden, Austria. claus.riedl@thermenklinikum-baden.atNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15982798

Citation

Riedl, Claus R., et al. "Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie's Disease: a Randomized Placebo-controlled Double-blind Prospective Clinical Study." European Urology, vol. 48, no. 4, 2005, pp. 656-61.
Riedl CR, Sternig P, Gallé G, et al. Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective clinical study. Eur Urol. 2005;48(4):656-61.
Riedl, C. R., Sternig, P., Gallé, G., Langmann, F., Vcelar, B., Vorauer, K., Wagner, A., Katinger, H., & Pflüger, H. (2005). Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective clinical study. European Urology, 48(4), 656-61.
Riedl CR, et al. Liposomal Recombinant Human Superoxide Dismutase for the Treatment of Peyronie's Disease: a Randomized Placebo-controlled Double-blind Prospective Clinical Study. Eur Urol. 2005;48(4):656-61. PubMed PMID: 15982798.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease: a randomized placebo-controlled double-blind prospective clinical study. AU - Riedl,Claus R, AU - Sternig,Peter, AU - Gallé,Günter, AU - Langmann,Florian, AU - Vcelar,Brigitta, AU - Vorauer,Karola, AU - Wagner,Andreas, AU - Katinger,Hermann, AU - Pflüger,Heinz, PY - 2005/01/21/received PY - 2005/04/19/accepted PY - 2005/6/29/pubmed PY - 2006/6/1/medline PY - 2005/6/29/entrez SP - 656 EP - 61 JF - European urology JO - Eur Urol VL - 48 IS - 4 N2 - 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. SN - 0302-2838 UR - https://wwww.unboundmedicine.com/medline/citation/15982798/Liposomal_recombinant_human_superoxide_dismutase_for_the_treatment_of_Peyronie's_disease:_a_randomized_placebo_controlled_double_blind_prospective_clinical_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(05)00256-3 DB - PRIME DP - Unbound Medicine ER -