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

Abstract

Patient-reported outcome measures (PROMs) play a pivotal role when recommending medical interventions. There is a lack of prospective studies directly comparing PROMs after transrectal (TR-Bx) and transperineal prostate biopsy (TP-Bx). We conducted a prespecified comparative analysis of PROMs from the ProBE-PC randomized trial. Eight hundred forty men were randomized to TR-Bx or TP-Bx under local anesthesia (LA). Participant-reported Numerical Rating Scale pain scores at various time points were collected, with score ≥ 4 defined as clinically significant pain. Prebiopsy and postbiopsy International Prostate Symptom Score (IPSS), IPSS-quality of life (QoL), and International Index of Erectile Function-5 were analyzed including minimum clinically important change in IPSS, IPSS-QoL, and International Index of Erectile Function-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 (<i>P</i> < .001). Compared with TR-Bx, clinically significant pain 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%; odds ratio 1.84; 95% 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%, <i>P</i> = .009, and 31% vs 22%, <i>P</i> < .01). Compared with TR-Bx, higher rates and increased level of pain, as well as increased urinary dysfunction, were reported after TP-Bx. This information is clinically relevant during patient counseling regarding prostate biopsy procedures.