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

PURPOSE: 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. MATERIALS AND METHODS: 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. CONCLUSIONS: 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.