Participant-Reported Outcome Measures Following Transrectal and Transperineal Prostate Biopsy in a Randomized Clinical Trial

Patient-reported outcome measures (PROMs) play a pivotal role when recommending medical interventions. There is a lack of prospective studies directly comparing PROMs following transrectal (TR-Bx) and transperineal prostate biopsy (TP-Bx). We conducted a pre-specified comparative analysis of PROMs from the ProBE-PC randomized trial. 840 men randomized to TR-Bx or TP-Bx under local anesthesia (LA). Participant-reported Numerical Rating Scale (NRS) pain scores at various time points were collected, with score ≥ 4 defined as clinically significant pain (csPain). Pre- and post-biopsy IPSS, IPSS-quality of life (QoL), and IIEF-5 were analyzed including minimum clinically important change in IPSS, IPSS-QoL and IIEF-5 scores. Higher pain scores were reported by patients undergoing TP-Bx than TR-Bx at 3 time points: LA injection, evening of the procedure, and Day 3 (p< 0.001). Compared to TR-Bx, csPain was reported more frequently with TP-Bx during LA injection (3% vs 38%; odds ratio, 19.39; 95% CI, 6.57-10.28), and on the evening of procedure (11% vs 19%; OR 1.84; CI 1.21-2.79). Increasing experience with TP-Bx between the first and later quartiles of participants did not influence pain scores. Findings were confirmed on adjusted multivariable analysis. Clinically important worsening of IPSS and IPSS-QoL was reported more frequently after TP-Bx than TR-Bx (28% vs 18% p=0.009, and 31% vs 22%, p < 0.01). Compared to TR-Bx, higher rates and increased level of pain, as well as increased urinary dysfunction, were reported following TP-Bx. This information is clinically relevant during patient counseling regarding prostate biopsy procedures.