Absence of race/ethnicity reporting in clinical trials of true minimally invasive surgical therapies for the treatment of benign prostatic hyperplasia.

Abstract

Objective: To assess the extent of racial reporting and enrolment in RCTs of minimally invasive surgical therapies (MIST) for the office-based treatment of benign prostatic hyperplasia (BPH).

Methods: A systematic review was conducted for RCTs assessing six office-based MISTs: transurethral microwave thermotherapy, prostatic artery embolization, prostatic urethral lift, temporary implantable nitinol device, water vapor thermal therapy, and Optilume. MEDLINE, Embase, and the Cochrane CENTRAL databases were searched up to November 3rd, 2023. Publications were excluded if they 1) did not address one of the aforementioned office-based MISTs for the treatment of BPH; 2) were not RCTs; 3) were an abstract or conference proceeding; or 4) were not published in English. In addition to study characteristics, data about racial reporting was collected. Two independent reviewers completed screening at title, abstract, and full-text levels, with conflicts resolved by consensus with a third reviewer.

Results: A total of 61 publications representing 37 unique RCTs (n=4027 unique patients) were reviewed, with publication years spanning from 1993 to 2023. TUMT was the most frequently studied MIST. Most publications (79%) were based solely in Europe or North America. Over 50% of the publications were multicenter trials. None of the included publications reported on race/ethnicity of study participants.

Conclusion: None of the 61 included publications of RCTs of office-based MISTs provided information on racial/ethnic composition of study participants. There is a staggering gap in the standardization of race/ethnicity reporting and enrolment within RCTs of MISTs. More granular data on race/ethnicity allows for better generalizability and equity.