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, is a study site for a new exciting treatment for benign prostatic hypertrophy (BPH).  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 Symtpoms (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). 

FIS and FUP were one of only 12 practices across Europe and the US that were awarded inclusion into a sponsored trial, run by Merit Medical, due to their extensive knowledge at treating prostate disease and interventional embolization techniques.  The physicians performing the procedure, Dr. Cliff Davis and Dr. Shawn Meader, received training and performed the procedure with the world’s expert, Dr. Carnavale in Sao Paulo, Brazil.

This FDA approved, randomized controlled trial is designed to evaluate outcomes of embolization of the prostate versus the current standard of care, Transuretheral Resection (TURP).  Embolization of the prostate is a minimally invasive procedure that involves access via the common femoral artery in the groin and placing a tiny catheter in the arteries that feed the prostate.  Microscopic particles are then infused into the prostate artery that block the flow, also called embolization.  Early results show that this procedure causes shrinkage of the prostate and significant improvement in symptoms for BPH.  Although the procedure is very promising, there have been no studies comparing prostate embolization to the current therapy of choice for BPH.  Patients enrolled in the study will be randomized, 66% will receive the embolization and 33% will receive TURP.  Follow-up will require patients to receive testing for at least one year and routine follow-up for up to 5 years.  This study is sponsored by a medical company and all procedures and tests will be billed to insurance or paid by the sponsor.

Dr. Clifford Davis, of Florida Interventional Specialists, has also designed a separate 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 these studies can be found here:

http://www.merit.com/products/default.aspx?code=pae

http://clinicaltrials.gov/show/NCT01789840

http://clinicaltrials.gov/show/NCT02167009

Florida Interventional Specialists is the largest and most specialized Interventional Radiology practice in Western Florida.  With 9 interventional radiologists and 1 neurointerventional radiologist we represent the most academic and largest clinical practice in the area.  Florida Urology Partners is the largest private urology group in Western Florida.  The offices of Dr. Bukkaputnam and Dr. Helal at Tampa General Hospital will be the site of much of the tests for the study and Tampa General Hospital is the site all of the procedures will be performed.  A physician or research coordinator will return your call and give you information on the study and possible enrollment.