Since prostate artery embolization was started as a treatment option for benign prostatic hyperplasia in March 2009, many distinguished Portuguese urologists have been invited to watch the procedure. However, only four have accepted the invitation, João Martins Pisco, Hospital Saint Louis, Lisbon, Portugal, tells Interventional News.
Where does the story begin?
Prostate artery embolization was started at St Louis Hospital in Lisbon in March 2009 after approval by an Ethics Committee. The medical team involved in the procedure includes a urologist who is the director of the Department of Urology and professor of Urology at the New University of Lisbon. Ever since we began carrying out these procedures, we have invited several distinguished urologists in Portugal to watch the procedure, however, only four have accepted the invitation.
In 2008, a local newspaper published news about prostatic artery embolization and stated that 27 cases were already performed. At that time, the urologists reacted and tried to stop prostatic artery embolization being performed through the College of Urology. Nonetheless the College of Urology has decided that there are no substantial reasons to abolish this innovative procedure.
What has happened since?
Shortly afterwards, in 2012, a lawsuit was filed against the medical team carrying out prostatic artery embolization and the St Louis Hospital by some urologists in Portugal. They stated that there were not enough validated data to support the efficacy of this technique when compared with other treatment options already being performed by urologists. Meanwhile, other reports supporting this innovative procedure have been published and presented in international medical conferences by our interventional radiology team in Portugal and others worldwide. The efficacy of the procedure and the outcomes being reported are quite similar.
The fact that the procedure is well-known and enthusiastically supported by international interventional radiology societies and that it has good mid-term published outcomes has strengthened the case for the efficacy of the procedure. Eventually, these legal processes begun by the urologists were dismissed without prejudice.
How is enrolment in the randomised trial progressing?
In 2014, we began a randomised sham trial to determine whether prostatic arterial embolization is an effective and safe treatment compared to a sham procedure, for the treatment of benign prostatic hyperplasia in patients with severe lower urinary tract symptoms not adequately controlled by medical therapy with alpha-blockers. The effectiveness and safety will be assessed by the International Prostate Symptom Score (IPSS) after six months. Patients will be randomised in a 1:1 ratio to either embolization or a sham procedure and evaluated at one, three and six months through several different imaging, biochemical and functional exams and through international validated questionnaires.
Two years ago, when the sham trial started, the College of Urology and the Portuguese Association of Urology were informed of the inclusion and exclusion criteria. However, we have had no patients referred to the trial by them. The patients enrolled in our trial were mostly self-referred, or referred by other previously-treated patients.
What is the current situation?
In March 2015, we reached the milestone of 1000 cases of prostatic artery embolization procedures at St Louis Hospital. There was extensive coverage from our national media on this occasion and a popular newspaper and TV channel came to our hospital and reported on the procedure’s success. The Portuguese Association of Urology then asked for an official statement from the College of Urology regarding prostatic artery embolization. We also asked for an official report from our national College of Radiology. In addition, statements and data from several distinguished interventional radiologists regarding prostatic artery embolization was collected as well as a report from CIRSE and SIR on the procedure.
The report from the Portuguese College of Urology is based on the fact that the fundamental action of prostatic artery embolization is not well known. In addition, they state that there are only a few prospective studies that evaluate the results of the procedure. Moreover, the Portuguese College of Urology notes that the actual published evidence for the efficacy and safety of prostatic embolization is not of high enough quality and that there are but few studies on the subject. The document draws attention to the single, prospective and randomised study, from China, comparing prostatic artery embolization and transurethral resection of the prostate (TURP) outcomes. It mentions the better results obtained by TURP in all parameters of the study, except hospitalisation time, which is not supported by the presented data.
We do not know what the next step of the Portuguese urologists who do not accept prostatic artery embolization will be—the future will tell us.