Development and validation of PEYRO-Q: a novel multidimensional patient-reported outcome measure for Peyronie's disease

Abstract

Background Peyronie's disease (PD) is a condition with significant physical, sexual, and psychological impact that is not fully captured by existing Patient-Reported Outcome (PRO) instruments.Aim To develop and preliminarily validate the PEYROnie's disease Questionnaire (PEYRO-Q), a novel multidimensional PRO questionnaire designed to provide a comprehensive and inclusive assessment of PD.Methods A prospective multicenter study was conducted between April and July 2025, enrolling 206 adult patients with PD. The PEYRO-Q, developed in accordance with COSMIN guidelines, includes 10 domains and 12 items assessing deformity severity and stability, pain, penile shortening, sexual function, erectile function, psychological distress, and sexual avoidance. Content validity was established through expert panel review. Internal consistency was evaluated using Cronbach's alpha, while test-retest reliability was assessed over a 2-week interval. Exploratory Factor Analysis (EFA) with promax rotation was performed to investigate the underlying structure.Outcomes Primary outcomes were internal consistency, test-retest reliability, and factor structure of the PEYRO-Q.Results The study population had a median age of 62 years, with most patients reporting moderate penile curvature and long-standing disease stability. The PEYRO-Q demonstrated excellent internal consistency (Cronbach's alpha = 0.90) and test-retest reliability (alpha = 0.89-1.00; Intraclass Correlation Coefficient, ICC up to 0.99). EFA supported a three-factor structure explaining 62.2% of total variance, corresponding to clinical/functional burden, disease perception and evolution, and psychological/behavioral impact. Moderate correlations between domains (eg, erectile aid use and psychological distress, r = 0.41) confirmed related but distinct constructs. The questionnaire allowed detailed and inclusive profiling of sexual function and psychological burden.Clinical Implications The PEYRO-Q offers a practical, inclusive, and comprehensive tool for assessing PD burden in both clinical practice and research settings.Strengths & Limitations Strengths include the multidimensional and inclusive design, strong psychometric performance, and multicenter prospective validation. Limitations include the predominantly Italian cohort, lack of longitudinal responsiveness data, absence of direct comparison with existing instruments, and limited clinical characterization such as plaque localization.Conclusion The PEYRO-Q is a reliable and clinically relevant PRO instrument for PD, warranting further validation to confirm responsiveness and cross-cultural applicability.