Può la TECAR (Trattamento Energetico Capacitivo Resistivo) Terapia avere un effetto terapeutico sulla malattia di La Peyronie? Studio di fase 2, randomizzato, in singolo cieco, con gruppo di controllo sham su 96 pazienti: rapida riduzione del dolore.

[automatically translated] Introduction and objective of the study We conducted a phase 2 randomized single-blind sham control group to evaluate the therapeutic effects of CRET therapy on 96 patients suffering from Peyronie's disease (IPP). Materials and Methods 96 patients with IPP randomized 2: 1 were divided into 2 grupp (treatment vs sham) and subjected to 3 sessions of CRET therapy in 3 consecutive days. Before the first treatment (V1) and 1 (FU1), 3 (FU3) and 9 (FU9) months from the end of the treatment we assessed pain (spontaneous or erect) by VAS (Visual Analogue Scale), the degree of curvature penile measuring the spontaneous angle of penile curvature with a protractor using the penile autofotografia and erectile ability (IIEF-5) of the members of both groups. Results Statistical analysis was effettuatat the Test T-Student. Statistical significance was taken to a p ≤ 0.05. All data were analyzed with statistical software Social Science Statistics. No subject in both groups was achieved a statistically significant reduction in penile curvature. Already at the end of the treatment session, then to FU1, there has been a reduction of at least 2 points VAS (p <0.01) of pain in 37 (58%) of patients in the treated group. In the sham group, on the contrary, the reduction of pain showed no scientific validity (p0.23). In the treated group compared to the sham group, we achieved an improvement in IIEF-5 score, although not statistically significant (p 0:06). The data obtained in FU1, They are similar to those obtained in FU3 and FU9, in both groups. Compliance was high: all patients have completed the treatment. No patients reported adverse events. Discussion The primary aim of our study was to find an effective therapy and free from adverse effects in the IPP. The CRET, method easy to perform and beautiful tolerated by patients, has shown excellent results for the treatment of fibrotic connective tissue diseases. We used the same therapeutic protocol used for the treatment of Dupuytren's disease. After a phase 1 conducted to assess the safety and tolerability of the treatment, we initiated a phase 2 randomized single-blind sham group for evaluating the effectiveness of treatment. The results obtained showed only effective in reducing pain. This could be the beginning of a new randomized protocol TECAR vs antiinflammatory regarding the reduction of pain. Conclusions This is the first randomized single-blind study, sham group, which demonstrates the effectiveness of TECAR in nell'IPP quickly reduce the pain.