BACKGROUND: Peyronie's disease (PD) is a fibrotic disorder of the tunica albuginea causing penile curvature and functional impairment. Platelet-rich plasma (PRP) injections have been proposed as a regenerative therapy, but current evidence remains limited and heterogeneous. OBJECTIVES: To evaluate the feasibility and safety of intralesional PRP combined with plaque puncture in men with stable PD, and to explore changes in penile curvature and patient-reported outcomes. MATERIALS AND METHODS: Prospective single-center interventional cohort study including 40 men with stable PD and measurable curvature ≥15°. Patients received three monthly intralesional injections of PRP combined with multisite plaque puncture. The primary endpoint was feasibility and safety, assessed by treatment completion rate and adverse events. Secondary exploratory endpoints included absolute and relative changes in penile curvature at Month 6, responder rate defined as ≥30% curvature reduction, patient satisfaction, quality of life, and predictors of response. RESULTS: All patients completed the planned three-injection protocol. Adverse events occurred in 42.5% of patients and were all Clavien-Dindo grade I. Mean curvature decreased from 43.4° to 36.3° (mean reduction 7.1°, 19.2%). Eight patients (20%) achieved ≥30% curvature reduction, below the prespecified Simon framework activity threshold. Responders had lower baseline curvature and a longer disease duration. Overall satisfaction was reported by 52.5% of patients. Exploratory analyses did not demonstrate significant associations between concomitant therapies and response. DISCUSSION: The modest anatomical response and absence of a comparator arm preclude conclusions on PRP efficacy. Mechanical plaque puncture represents a major confounding factor, as its independent biological effect cannot be excluded. Patient profile, lower baseline curvature, and longer disease duration may influence treatment response. CONCLUSION: Intralesional PRP combined with plaque puncture appears feasible and well tolerated in stable PD, with modest exploratory anatomical signals. The independent contribution of PRP cannot be determined without a sham-controlled design, and these findings should be considered hypothesis-generating.
Armand et al. (Thu,) studied this question.