December 16, 2019
Randomized, Sham-Controlled Trial Demonstrates Efficacy of Prostate Artery Embolization for Symptomatic BPH
December 16, 2019—A study published online ahead of print in European Urology evaluating prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) found that the “clearly superior efficacy” of PAE compared with a sham procedure supports the use of PAE in patients with typical symptoms associated with BPH. With late PAE pioneer João Martins Pisco, MD, as lead author, the investigators in this sham-controlled trial sought to provide evidence of the safety and efficacy of PAE to improve the lower urinary tract symptoms (LUTS) associated with BPH–LUTS/BPH.
As summarized in European Urology, the randomized, single-blind, sham-controlled superiority clinical trial was composed of 80 men, ≥ 45 years, with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic. Efficacy assessments were conducted at 6 and 12 months after randomization. One patient in the PAE group and three in the sham group did not complete the study.
Investigators randomized the patients 1:1 after successful catheterization of a prostatic artery to either PAE or a sham PAE procedure without embolization. After 6 months, all 38 patients randomized to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-month open period. An intention-to-treat analysis of all randomized patients was performed.
The coprimary outcomes were the change from baseline to 6 months in the International Prostate Symptom Score (IPSS) and the Quality-of-Life (QOL) score at 6 months evaluated with analysis of covariance and t test, respectively. Mean age was 63.8 ± 6.0 years with baseline IPSS of 26.4 ± 3.87 and QOL score of 4.43 ± 0.52.
At 6 months, the investigators found the following:
- 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 < .0001), and a better QOL score at 6 months (difference, 2.13; 95% CI, 1.57–2.68; P < .0001) than the patients in the sham arm.
- The improvements in IPSS and QOL were 13.6 ± 9.19 (P < .0001) and 2.05 ± 1.71 (P < .0001), respectively.
- Adverse events occurred in 14 (35%) 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.
Although noting that limitations of the study include that it was a single-center trial that was composed of only severe LUTS/BPH, and follow-up was limited to 12 months, the investigators concluded in European Urology that the improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect.
Discussing the impact of this trial with Endovascular Today, study investigator Tiago Bilhim, MD, commented, "These findings are very important as they are the first and only findings until now that prove that PAE is not a sham procedure, thus establishing definitely the 'true' or 'real' effect of PAE on LUTS in patients with BPH."
Dr. Bilhim continued, "Urologists are unanimous that for a new treatment procedure to be accepted for BPH patients suffering from LUTS, randomized controlled prospective trials must exist, comparing the treatment being tested with not only surgical therapies and medical therapies but also with a sham procedure. All treatments for LUTS in patients with BPH have a placebo component, thus it is essential to establish how much effect is due to the PAE and how much is due to a placebo effect. After this trial, it is very clear the proportion of the placebo effect in patients with LUTS and BPH being treated with PAE."
Regarding the investigators' determination of which forum to publish these findings, Dr. Bilhim noted, "We decided to target the urology community because one of the main goals of this study was to help establish PAE as a treatment option for patients with LUTS and BPH in the urology guidelines. We decided to publish specifically in European Urology because it is the highest impact factor journal in urology and one of the most renowned journals within urology."