NIH-supported study pits BPH devices against drugs
This article was originally published in The Gray Sheet
Executive Summary
Medtronic and Urologix are among firms standing to benefit from a study comparing minimally invasive surgical treatment of benign prostatic hyperplasia (BPH) using transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) to drugs. Efficacy of the devices, offered by such firms as Medtronic (TUNA) and Urologix (TUMT), first approved by FDA in 1996, will be compared to a regimen of finasteride (Proscar) and the alpha-1 inhibitor doxazosin (Cardura). The study will be run by The Minimally Invasive Surgical Therapies (MIST) Consortium, supported in part by both firms, and will be funded by $15 mil. from the National Institute of Diabetes & Digestive & Kidney Diseases at NIH. The protocol will include three-to-five-year follow-up, roughly through July 2009, on more than 700 men with moderate to severe symptoms...