Many patients experience pain, anxiety, and discomfort with prostate biopsy, which may discourage enrollment in active surveillance programs or follow-up biopsy. Guided meditation can significantly reduce pain and anxiety during percutaneous biopsy. We sought to evaluate the effectiveness of a brief mind-body intervention on patient-reported outcomes after prostate biopsy.
We performed a clinically-integrated randomized controlled trial of a brief mind-body intervention during biopsy compared to usual care at a single tertiary care center from 2018 to 2022. All patients offered transrectal ultrasound-guided prostate biopsy in the clinic with local anesthesia were eligible for enrollment. This clinically integrated trial was conducted simultaneously with a randomized controlled trial of 1-stage and 2-stage consent. The primary outcome was patient-reported pain, anxiety, discomfort, and tolerability on a visual-analog scale (0-10). A 15% improvement was prespecified as clinically relevant. We compared the proportion of men in each arm reporting a severe score (7-10) on any of the 4 scales using Fisher's exact test and then compared means for each scale separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate.
Of 263 eligible patients, 238 enrolled (119 per arm). One hundred seventy-two (72%) enrolled with 2-stage consent. A total of 37/94 (39%) and 38/102 (37%) patients randomized to usual care and intervention, respectively, reported severe scores in any of the 4 domains, a difference of 2.1% (95% confidence interval [CI] -13, 17%, P = 0.8). There was no evidence of a difference in mean postbiopsy anxiety (P = 0.3), discomfort (P = 0.09), pain (P = 0.4) or tolerability scores (P = 0.2).
A clinically meaningful benefit for this brief mind-body intervention during prostate biopsy is unlikely. Robust patient enrollment is feasible using 2-stage consent.
Urologic oncology. 2023 Nov 15 [Epub ahead of print]
Christopher D Gaffney, Emily A Vertosick, Sigrid V Carlsson, Xin Lin, Natalie Wolchasty, Robin Hardbattle, Andrew J Vickers, Behfar Ehdaie
Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY., Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Urology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden., Department of Integrative Medicine, Memorial Sloan Kettering, New York, NY., Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: .