Trimodal mini-invasive therapy for stable-phase Peyronie's disease: a two-center real-life prospective pilot study
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Introduction : Platelet-Rich Plasma (PRP) into penile plaques has emerged as a promising approach for treating acquired penile curvature in men with stable-phase Peyronie's Disease (PD), although it is still investigational. We aimed to analyze the preliminary results of a two-center real-life prospective pilot study. Material and methods : Data from 38 patients undergoing PRP injections were prospectively collected. All patients underwent dynamic penile Color Doppler-duplex ultrasound (CDDU) at baseline and follow-up to assess penile hemodynamic parameters and objective measurement of penile morphometric parameters. Similarly, all men completed the International Index of Erectile Function (IIEF) and the Peyronie's Disease Questionnaire (PDQ) at baseline and follow-up. According to the center, PRP was obtained using double or single blood centrifugation (2-cycle vs. 1-cycle group). All patients received two injections, each consisting of an average of 8 mL of PRP, administered 4-week apart. Thereafter, patients started using tadalafil 5 mg one-daily. Likewise, one week apart from PRP injections, patients started daily penile stretching with Vacuum Device (5-15 minutes daily). All patients had three-month follow-up assessment, including IIEF-EF, PDQ and CDDU. Results : Median (IQR) age and BMI were 60.5 (55, 66.8) years and 25.9 (24.1, 27.3) kg/m 2 , respectively. Overall, 22 (57.9%) patients received PRP injection after two centrifuge cycles and 16 (42.1%) after one centrifuge cycle. In the 2-cycle group, baseline penile curvature was 45° (37, 70), decreasing to 40° (30, 50) at three-month follow-up (p=0.002). Conversely, in the 1-cycle group, baseline curvature was 60° (50, 66), decreasing to 50° (40, 56) at three-month follow-up (p=0.008). Overall, median baseline penile curvature was 55° (45, 70) and decreased to 45° (30, 55) after PRP treatment, with a median reduction of 10° (0, 15) (p<0.001). Median PDQ scores at baseline were 22 (20.5, 23) in the 2-cycle group and 22.5 (20, 32.75) in the 1-cycle group, respectively. At three-month follow-up, PDQ decreased to 20.5 (16, 22) and 18 (14.5, 22), respectively in the two groups (both p≤0.006). For both groups, IIEF-EF scores and CDDU parameters did not change over time. Median plaque diameter decreased from 18 (9.3, 21.7) and 8 (6, 9.6) to 17 (9.8, 20) and 7.5 (5, 9.7) mm, respectively, without statistical significance. No treatment-emergent adverse events were reported. Conclusions : Preliminary findings indicate that PRP injections are a safe therapeutic option to ameliorate penile morphometric parameters and PDQ scores in men with bothersome penile curvature in stable-phase PD. The observed decrease in penile curvature is still inadequate to extrapolate clinically significant long-term outcomes.