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 !45 yr 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 AE 6.0 yr, baseline IPSS 26.4 AE 3.87, and QoL score 4.43 AE 0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p < 0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p < 0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6 AE 9.19 (p < 0.0001) and 2.05 AE 1.71 (p < 0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. Conclusions: The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. Patient summary: Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.

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Background Programs seek to expose trainees to research during residency. However, little is known in any formal sense regarding how to do this effectively, or whether these efforts result in more or better-quality research output. Questions/purposes The objective of our study was to evaluate a dedicated resident research program in terms of the quantity and quality of resident research peerreviewed publications. Specifically we asked: (1) Did residents mentored through a dedicated resident research program have more peer-reviewed publications in higherimpact journals with higher citation rates compared with residents who pursued research projects under a less structured approach? (2) Did this effect continue after graduation? Methods In 2006, our department of orthopaedic surgery established a dedicated resident research program, which consisted of a new research policy and a research committee to monitor quality and compliance with this policy. Peer-reviewed publications (determined from PubMed) of residents who graduated 6 years before establishing the dedicated resident research program were compared with publications from an equal period of the research-programdirected residents. The data were assessed using descriptive statistics and regression analysis. Twenty-four residents graduated from 2001 to 2006 (before implementation of the dedicated resident research program); 27 graduated from 2007 to 2012 (after implementation of the dedicated resident research program). There were 74 eligible publications as defined by the study inclusion and exclusion criteria.Results Residents who trained after implementation of the dedicated resident research program published more papers during residency than did residents who trained before the program was implemented (1.15 versus 0.79 publications per resident; 95% CI [0.05,0.93]; p = 0.047) and the journal impact factor was greater in the group that had the research program (1.25 versus 0.55 per resident; 95% CI [0.2,1.18]; p = 0.005). There were no differences between postresidency publications by trainees who graduated with versus without the research program in the number of publications, citations, and average journal impact factor per resident. A regression analysis showed no difference in citation rates of the residents' published papers before and since implementation of the research program. Conclusions Currently in the United States, there are no standard policies or requirements that dictate how research should be incorporated in orthopaedic surgery residency training programs. The results of our study suggest that implementation of a dedicated resident research program improves the quantity and to some extent quality of orthopaedic resident research publications, but this effect did not persist after graduation. Level of Evidence Level III, therapeutic study.

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