THURSDAY, Feb. 19, 2004 (HealthDayNews) --Celsion Corp.'s Prolieve Thermodilation system won FDA approval Thursday to treat enlarged prostate, medically known as Benign Prostatic Hyperplasia (BPH).
The in-office device combines heat and urethral dilation and usually provides significant symptom improvement in two weeks, the company says in a prepared statement. A one-year, 14-center clinical trial found that men using Prolieve reported better symptom improvement after three months than those who had used a frequently prescribed BHP drug, Proscar, the statement adds.
BHP affects an estimated 9 million men in the United States and more than 26 million men worldwide, the company says. The disorder, whose risk increases with age, affects about 90 percent of all men over age 75 at some point in their lives, Celsion says.
For more information about enlarged prostate, visit the U.S. government's National Kidney and Urologic Diseases Information Clearinghouse.