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NIH launches new study to compare prostate surgery and drugs

BETHESDA, MARYLAND - The Minimally Invasive Surgical Therapies (MIST) Consortium for Benign Prostatic Hyperplasia (BPH) has launched a new study to compare long-term benefits and risks of transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) to a regimen of the alpha-1 inhibitor alfuzosin and the 5-alpha reductase inhibitor finasteride. The National Institute of Diabetes and Digestive and Kidney Diseases at NIH, part of the Department of Health and Human Services, is investing more than $15 million in the study.

TUNA and TUMT use heat to destroy part of the enlarged prostate to improve urine flow and symptoms. Early studies suggest that these procedures reduce the occurrence of erection or bladder control side effects, which occur more often with the traditional surgery for BPH, known as transurethral resection of the prostate (TURP). TUNA and TUMT are said to be minimally invasive in part because they typically are done with local anesthesia and men go home the same day, whereas TURP requires general anesthesia and an overnight hospital stay. As for drug therapy, a recently published large randomized study showed that a regimen of finasteride (Proscar) and the alpha-1 inhibitor doxazosin (Cardura) prevents progression of BPH in a significant percentage of symptomatic men and it helps men at high risk avoid surgery.

"It's easy to see why drug therapy, TUNA and TUMT have been embraced by many urologists and patients," said Leroy M. Nyberg Jr., Ph.D., M.D., director of NIDDK's urology trials. "Yet, we don't know which treatment is more effective in the long run and, for the most part, who would be better served by the drug combination versus one of the minimally invasive therapies."

By July 2006, researchers plan to have recruited and randomly assigned more than 700 men with moderate to severe symptoms and no prior prostate surgery to one of the three MIST therapies. The men, age 50 and over, will be
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Contact: Mary Harris
mary_harris@nih.gov
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
16-Nov-2004


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