Two New Studies Test Varying Treatments for Enlarged Prostate

Enlarged Prostate Treatment

A sensation of not emptying the bladder completely; the need to get up multiple times in the night to use the bathroom; and straining or waiting followed by slow, weak, or interrupted urination " all are signs of an enlarged prostate, a common diagnosis for almost all men as they get older.

Two new studies at the University of Colorado at Denver and Health Sciences Center are currently recruiting males, age 45 and older, with unpleasant urinary symptoms caused by an enlarged prostate " also known as benign prostatic hyperplasia (BPH). The studies will explore two very different treatments, one using the drug Cialis and the other using Botox injected into the prostate.

"The aim of both of these studies is to uncover newer and more effective treatment options for BPH," said E. David Crawford, MD, professor of urologic oncology at the UCDHSC School of Medicine and principal investigator for both studies. "Whether the treatment comes in the form of an oral drug like Cialis or through the use of Botox injections, a reduction in the prostate size or a weakening of the unpleasant and often painful effects of enlarged prostate are the goal. There is a 90 percent chance that a man will have BPH as he ages " it is extremely common."

The prostate is a walnut-sized gland that forms part of the male reproductive system. The gland is located just below the bladder where urine is stored and surrounds the urethra (the canal through which urine passes out of the body). As the prostate grows, it makes urination difficult and oftentimes painful.

Though it is normal for the prostate to continue to grow during most of a man's life, the enlargement doesn't usually cause problems until late in life. Very few men will experience symptoms of BPH before age 40, but more than half of men in their sixties and as many as 90 percent in their seventies and eighties have some symptoms of BPH.

Previous studies have showed that injecting the botuminum toxin (Botox) directly into the prostate causes it to shrink 30 percent to 50 percent, and the results last a year or more. Patients in the Botox study will be randomized to one of two dose levels of the toxin, either a 100 unit dose or a 300 unit dose. Participants will be involved with the study for 12 months and must be at least 50 years old.

Participants in the study with the drug tadalafil, also known under its market name Cialis, will be randomly assigned to either a placebo or 20 milligrams of the drug once a day for 12 weeks. The multi-center study is enrolling approximately 140 subjects at 20 sites in North America. Participants must be at least 45 years old.