Pilot study on liposomal recombinant human superoxide dismutase for the treatment of Peyronie's disease.
OBJECTIVE
To assess the efficacy and safety of liposomally encapsulated recombinant human superoxide dismutase (lrhSOD) for the treatment of Peyronie's disease.


METHODS
In an uncontrolled phase-2 study, 20 patients with Peyronie's disease were treated with a gel containing lrhSOD (1.5 mg/g). Patients with penile deviation of >45 degrees or plaque calcifications of >5 mm were regarded as candidates for surgical correction and excluded from this study.


RESULTS
Elimination of pain was observed in 7/13 patients (in 2 patients after only 3 days of therapy), and an almost complete resolution of pain was reported by the remaining 6/13 patients. Plaque size was reduced in 8/14 patients. Minimal improvement of penile deviation was observed in 3/12 patients. Post-therapeutic improvement of sexual function, mainly due to cessation of pain, was reported by 12/15 patients. No systemic or local side effects were observed.


CONCLUSIONS
In the present study, 100% pain relief as well as a plaque size reduction in 56% of Peyronie's disease patients were observed after a maximum of 6 weeks of lrhSOD therapy. The convenience and safety of lrhSOD gel therapy were superior compared to other current regimens. The present results suggest that lrhSOD gel is a promising treatment for patients with early stage Peyronie's disease. Early institution of lrhSOD therapy may prevent disease progression to penile deviation. The present preliminary results are the basis of a placebo-controlled randomized study.
Riedl
C R
CR
Department of Urology and Ludwig Boltzmann Institute of Andrology, Municipal Hospital Lainz, Vienna, Austria. ric@uro.khl.magwien.gv
Plas
E
E
Vorauer
K
K
Vcelar
B
B
Wagner
A
A
Pflüger
H
H
D000328:Adult; D000368:Aged; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010411:Penile Induration / Q000188:drug therapy*; D010865:Pilot Projects; D011994:Recombinant Proteins; D013482:Superoxide Dismutase / Q000008:administration & dosage*
D016166:Free Radical Scavengers; D008081:Liposomes; D011994:Recombinant Proteins; D013482:Superoxide Dismutase