Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia
Abstract
BACKGROUND
Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking.
OBJECTIVE
To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH.
DESIGN, SETTING, AND PARTICIPANTS
A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study.
INTERVENTION
Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively.
RESULTS AND LIMITATIONS
Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 38 participants or records.
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