Pain in Men Undergoing Transperineal Free-Hand mpMRI Fusion-Targeted Biopsies under Local Anesthesia: Outcomes and Predictors from a Multicenter Study of 1,008 Patients.

BACKGROUND Several TP biopsy series proved feasibility under LA. However, there is a lack of large analysis detailing pain outcomes and factors influencing pain. MATERIALS AND METHODS From 2016 to 2019 we performed a multicenter prospective study in men undergoing mpMRI-TPFBx (target+systematic cores) under LA. Primary outcomes were: i) pain scores (assessed through a 0-10 point NRS); ii) identification of factors associated with severe pain. Secondary outcome was to evaluate pain influence on csPCa target cores detection. RESULTS We included 1,008 men undergoing TPFBx under LA. Mean NRS pain scores were 3.9±2.1 at LA administration, 3.1±2.3 when performing Bx. Pain was not associated with lower csPCa detection on targeted cores (p=0.23 and p=0.47 depending on csPCa definition). On multivariate analysis, age (OR 0.96, 95% CI 0.94-0.99) and severe anxiety (OR 2.99, 95% CI 1.83-4.89) were a protective and risk factor respectively, for severe biopsy pain. Procedural time was also associated with an increased risk of experiencing severe biopsy pain (OR 1.04, 95% CI 1.00-1.08). If aiming to test possible anxiety preventive measures effects on pain, an anxiety cut off >6 NRS would decrease to 13% the number of patients being treated whilst identifying 56% of those experiencing severe pain. CONCLUSIONS TPFBx under LA yield moderate pain. Pain does not influence csPCa target detection. Patients anxiety predicts pain. A NRS-based anxiety assessment may be used to identify those at higher risk of experiencing severe pain in men undergoing TPFBx.