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RESEARCH PRODUCT

SICUREZZA E TOLLERABILITA' DEL TRATTAMENTO LOCALE CON ILOPROST IN PAZIENTI AFFETTI DA MALATTIA DI LA PEYRONIE. STUDIO PILOTA DI FASE 1 E PROPOSTA DI NUOVO QUESTIONARIO PER LA VALUTAZIONE SINTOMATOLOGICA

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Purpose. Intralesional therapy is a less invasive method for the treatment of Peyronie's disease. The objective of this study was to evaluate safety and tolerability of intralesional injections of Iloprost (I2 Prostacyclin analogue) for its property to suppress in fibroblasts CTFG (Connective tissue growth factor) production, which acts in concert with TGF-ß to stimulate the fibrotic process.?Methods. Nineteen patients with Peyronie's disease were preliminarily evaluated by considering the degree of penile curvature, plaque size and local and systemic symptoms. Each patient then received weekly intralesional injections of 200ng of Iloprost in 1 ml of normal saline for 4-5 weeks. If tolerated, the single dose increased weekly to the maximum of 400 ng (2 mL). Results. The treatment has shown that all patients seem to well tolerate a 200 ng Iloprost dose; 7 of them reached a 300 ng dose and 6 tolerate a 400 ng dose without showing side effects. There was no placebo control group in this study.?To evaluate the efficacy of the treatment, the absence of objective parameters (except for the auto-photograph of penis in erection) led us to develop a subjective questionnaire that was given to all patients to assess sexual function, pain reduction, ecc. Conclusions. Due to the relatively small size of the sample, the efficacy evaluation has been restricted to check the questionnaire reliability. Iloprost is well tolerated to a dose of 400ng in the local treatment of Peyronie's disease.