Florida Interventional Specialists

Minimally Invasive Specialists:
Providing Better Outcomes and Faster Recovery

Tampa: (813) 844-4570

Sarasota: (941) 552-5500

 

Benign Prostatic Hypertrophy Clinical Study Treatment


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Benign Prostatic Hypertrophy Clinical Study Treatment

"BPH affects approximately
50% of men at the 60 and
75% of men at the age 80."

Florida Interventional Specialists, in cooperation with Florida Urology Partners and the University of South Florida, has been involved a study on an exciting treatment for benign prostatic hypertrophy (BPH) since 2014.  BPH affects approximately 50% of men at the age of 60 and 75% of men at the age of 80. Symptoms of BPH, called Lower Urinary Tract Symptoms (LUTS) can often be controlled with medications but many patients have worsening symptoms despite the best medical care.  In many of these patients, quality of life suffers and patients have difficulty sleeping due to nocturia (waking to urinate). 

Dr. Clifford Davis, of Florida Interventional Specialists, has designed a study utilizing Prostate Artery Embolization (PAE) for BPH specifically for patients at Tampa General Hospital.  FIS is one of only a few practices in the country that have their own FDA approved IDE (investigational device exemption) for the treatment of BPH with PAE. Although several other institutions are performing PAE, most are not FDA approved.  The IDE approved study means that experts at the FDA reviewed the study protocol and made recommendations to make the study the most beneficial and safe for enrolled patients.  This study is specifically for patients with large prostates that would require more invasive surgery for treatment. PAE offers these patients a less invasive treatment option or possibly the only option in patients with high risks for surgery.  The study is designed to evaluate the safety and efficacy of the procedure and is not randomized; all patients that meet study criteria will receive Prostate Artery Embolization.   In this study the procedure and tests will be billed to insurance and if the insurance company will not authorize the treatment, the hospital may request payment prior to the procedure.  Billing for this procedure is handled on a case by case basis PRIOR to any treatment. 

More information regarding the studies can be found here:

http://clinicaltrials.gov/show/NCT02167009