Since 2007, he has worked with urologists at the University of Sao Paulo to develop an alternative BPH treatment for a subset of patients with moderate to advanced stage BPH. Urologist Alberto Antunes, MD, will be presenting a moderated poster May 17, 10am during the AUA BPH session.
An estimated 25% of BPH patients fail medication therapy or experience complication from TURP. In the Sao Paulo Phase I study, 11 patients with acute urinary retention and indwelling catheters (considered TURP candidates) were selected for the trial. All patients were thoroughly evaluated by the urologist utilizing a TURP pre-op protocol (urodynamic testing, PSA, and biospy if concerned). MRI and rectal ultrasound were part of the IR protocol with urology to better evaluate the prostate reduction size.
While the PAE technique models the uterine fibroid embolization procedure commonly done by interventional radiologists, Dr. Carnevale recommends the prostate anatomy (representing five different arterial branches) be evaluated with angiography and contrast. He noted, these arteries are often represented by tortuous corkscrew vasculature; if these arteries are feeding the prostate, they should be embolized to achieve better results. The PAE procedure was performed outpatient with local anesthetic. Dr. Carnevale used a microcatheter to navigate the prostatic arteries and injected 300-500 micron Embosphere® microspheres until the endpoint of statis was achieved bilaterally.
After three years of follow-up in two patients and a minimum of 5 months follow-up in all patients; 91% clinical success was achieved (12 PAE procedures/9 bilateral and 3 unilateral). Symptom relief and catheter remover was achieved in 10 patients (uni-and bilateral) with a mean time of 12 days. The one patient whose catheter could not be removed, had a prostate reduction size of 5% was referred to TURP. Surgeons reported less than normal bleeding during the TURP. In two patients with 18-month imaging follow-up, 32.9% prostate reduction was observed. In six months, 9 patients had achieved 32.4% prostate reduction. In this patient group, only mild discomfort in the prostate area was reported, patients received NSAIDS. Two patients had diarrhea and one episode of hematuria was observed on the ninth operative day while the patient had the indwelling catheter. Catheter was later removed and a small bladder ischemia was observed at the MRI one-month follow-up. Three patients reported one to two episodes of mucous and blood in the feces .Dr. Carnevale believes this could be related to the rectum proximity to the prostate. The International Prostate Symptom Score (IPSS) for the patient group after the procedure ranged from 7.1 to 4. Overall, the QoL rating by patients indicated they were very pleased with the outcome based on LUTS relief.
In conclusion, Dr. Carnevale stated, “PAE can safely and effectively treat advanced benign prostatic hyperplasia for patient who are poor surgical candidates for TURP, reducing the average prostate volume by 30% and improving quality of life for patients who otherwise are living with indwelling catheters. A multidisciplinary approach must be enrolled to obtain the best results.”
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Presented by Francisco Cesar Carnevale, MD, PhD at the Global Embolization Symposium and Technologies (GEST) conference.
Reported by Karen Roberts, Medical Writer, UroToday.com
View slides presented by Dr. Carnevale at the conference
