US IDE trial finds embolization “safe and efficacious” for benign prostatic hyperplasia

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Riad Salem

A prospective US FDA-approved investigational device exemption (IDE) study has demonstrated significant improvement in lower urinary tract symptoms secondary to benign prostatic hyperplasia and reduction in total prostate and central gland volumes in patients treated with prostate artery embolization.

The study was published online on 20 July 2018 in the journal, Urology.

The triallists, including Riad Salem and colleagues from Northwestern University, Chicago, USA, enrolled 45 men with prostate volume greater than 40g. The patients enrolled were classified as having an International Prostate Symptom Score (IPSS) of greater than 13; peak flow rate (Qmax) of less than or equal to 12mL/; and voided volume greater than or equal to 125ml.

“We must all strive to raise the level of evidence with interventional therapies. Prostate artery embolization is no exception. Our group was intrigued by initial reports from pioneers of the procedure in Portugal, Brazil and the USA. As a result, we embarked on a truly multidisciplinary prospective phase 2 study. It is with such prospective investigations that the entire field moves forward and the scientific level of dialogue is raised,” Salem told Interventional News.

Patients were evaluated with questionnaires (IPSS, quality-of-life [QoL]), International Index of Erectile Function (IIEF), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)] and clinical measures (post-void residual volume [PVR] and Qmax at baseline, one, three, and 12 months after prostate artery embolization.) Baseline and six-month total prostate and central gland volumes were obtained.

Prostate artery embolization results

As reported in Urology, 45 patients with a mean prostate volume of 99cc (range: 30–214g) were treated over the course of the three-year study. At one month, there were significant improvements in IPSS (p<0.0001), quality of life score (p<0.0001) and Qmax (p<0.0001) that were sustained at the three-month follow-up. At six months, there were significant improvements in IPSS (p<0.0001) and QoL (p<0.0001) that were sustained at one-year follow-up.

Further results from the study showed that there were reductions in post-void residual volume that reached significance at certain time points including at the six-month and one-year marks. Median decreases in total prostate volume and central glad volume were 18% (p=0.0001) and 27% (p=0.0001), respectively. These findings of prostate size reduction will soon be published in a separate analysis in Abdominal Radiology.

The authors reported self-limited adverse events that included dysuria (n=13), haematuria (n=6), haematospermia (n=2), urinary frequency (n=3) and retention (n=2). There were no severe adverse events, non-target embolization, or adverse effects on erectile function or sexual health.

“We were able to complete all 45 patients without non-target embolization or any other significant adverse events. Most importantly, there were no adverse effects on sexual function. It is exciting to be generating data that validate those of ROPE UK and other publications. In my opinion, there has now been sufficient data to support embolization as a legitimate treatment option in selected patients. It is time to start offering embolization as one of many standards of care to patients afflicted with benign prostatic hyperplasia,” Salem told Interventional News.

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