Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia (PARTEM): a randomised, multicentre, open-label, phase 3, superiority trial
Abstract
Background: Prostatic artery embolisation (PAE) is a minimally invasive treatment of symptomatic benign prostatic hyperplasia (BPH). Our aim was to compare patient’s symptoms improvement after PAE and medical treatment. Methods: A randomised, open-label, superiority trial was set in 10 French hospitals. Patients with bothersome lower urinary tract symptoms (LUTS) related to BPH ≥50 ml resistant to alpha-blocker monotherapy were randomly assigned (1:1) to PAE or Combined Therapy ([CT], oral dutasteride 0·5 mg / tamsulosin hydrochloride 0·4 mg per day). Randomisation was stratified by centre, International Prostatic Symptom Score (IPSS) and prostate volume with a minimisation procedure to ensure balanced allocation. The primary outcome was the 9-month change in IPSS. Primary and safety analysis were done according to the intention-to-treat (ITT) principle among patients with an evaluable primary outcome (modified ITT). ClinicalTrials.gov Identifier: NCT02869971. Findings: Ninety patients were randomised from September 2016 to February 2020, and 44 and 43 patients assessed for primary endpoint in PAE and CT groups respectively. The 9-month change of IPSS was -10·0 (95% confidence interval [CI]: -11·8 to -8·3) and -5·7 (95% CI: -7·5 to -3·8) in the PAE and CT groups, respectively. This reduction was significantly greater in the PAE group than in the CT group (-4·4 [95% CI: -6·9 to -1·9], P=0·0008). The IIEF-15 score change was 8·2 (95% CI: 2·9 to 13·5) and -2·8 (95% CI: -8·4 to…
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: 44 participants or records.
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