Urologic Diseases Research Updates
Winter 2009

Research News

Alfuzosin Fails to Reduce Prostatitis Symptoms

The commonly prescribed drug alfuzosin failed to significantly reduce chronic prostatitis symptoms in men who participated in a 12-week clinical trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The results were reported December 18, 2008, in the New England Journal of Medicine.

“Although these results are disappointing, it is just as important to find out what doesn’t work as it is to know what does,” said NIDDK Director Griffin P. Rodgers, M.D., M.A.C.P. “We have conclusively shown that a drug commonly prescribed for men with chronic prostatitis did not significantly reduce symptoms compared with a placebo.”

Alfuzosin is an alpha blocker, a class of drugs that relaxes the smooth muscle of the bladder and prostate.

A Common Problem

Chronic prostatitis, which has no known cause and no uniformly effective therapy, is the most common type of prostatitis seen by physicians. Men with this condition experience pain in the genital and urinary tract areas, lower urinary tract symptoms such as pain in the bladder area and during urination, and sexual problems that can severely affect their quality of life. Population-based surveys estimate that 6 to 12 percent of men have prostatitis-like symptoms.

A total of 272 men diagnosed with chronic prostatitis were randomly assigned to take either alfuzosin or an identical-looking placebo. Of these, 233 men completed the trial. The primary outcome was a decrease, or improvement, in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least four points over 12 weeks of treatment.

A four-point decrease in the NIH-CPSI score has been shown to be the minimal clinically significant difference perceived by patients as beneficial. The index measures the three most important symptoms of chronic prostatitis—pain, urination problems, and negative effects on quality of life.

Although 49.4 percent of men in both groups experienced a four-point or greater score reduction, the alfuzosin group showed no improvement over the placebo group. “A 12-week course of alfuzosin as compared with placebo did not result in a clinically meaningful reduction in symptoms, as measured by the NIH-CPSI,” said lead study author J. Curtis Nickel, M.D., professor of urology at Queen’s University in Kingston, Ontario, Canada.

Lack of Evidence

Despite a lack of rigorous evidence supporting the use of antibiotics or alpha blockers for chronic prostatitis, more than 75 percent of primary care physicians often prescribe antibiotics and more than 50 percent regularly prescribe alpha blockers such as alfuzosin for the condition, according to a recent NIDDK-supported survey.

Previous studies of alpha blockers conflict. Whereas several smaller trials showed alpha blockers improved prostatitis symptoms, a larger study that included men with long-standing symptoms and previous alpha blocker use showed no improvement. The current study tested whether alpha blockers might be more beneficial to men with recently diagnosed prostatitis and therefore was limited to men who had symptoms for 2 years or less and had never before taken alpha blockers.

“Our findings do not support the use of alpha blockers for treating new cases of chronic prostatitis,” said Nickel. “But the results of our study will inform future clinical trials of alpha blockers and other potential therapies.”

More information about the Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome can be found at www.ClinicalTrials.gov.

Publications about prostate problems are available from the National Kidney and Urologic Diseases Information Clearinghouse at www.kidney.niddk.nih.gov/kudiseases/a-z.asp.

NIH Publication No. 09–5743
March 2009

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