Urologic Diseases Research Updates

Clinical Trial Tests Treatment for Chronic Prostatitis

Recruitment for a clinical trial to test the effectiveness of the drug pregabalin in treating chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is in full swing.

The syndrome, which can afflict men of any age but predominates in younger to middle-aged men, is responsible for about 2 million office visits annually in the United States. Symptoms, which include pelvic pain with or without accompanying urologic symptoms, may go away and return without warning.

Neither standardized diagnostic tests nor evidence-based treatments currently exist for this condition. Although physicians frequently prescribe antibiotics as an initial treatment, their effectiveness has never been demonstrated in randomized clinical trials. Pregabalin is an anti-epileptic medication that also affects chronic pain and is used to treat post-herpetic neuralgia and diabetic neuropathy.

Ten clinical treatment centers, including one in Canada, are recruiting men, who must be at least 18 years old, for the trial. The enrollment goal is 318 participants, according to Leroy Nyberg, Ph.D., M.D., director of urology and urology centers programs at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Nyberg said it is still too early to report on the trial’s progress.

To be eligible for the study, participants must have failed to respond to previous treatments and must have had symptoms for at least 3 of the preceding 6 months. Pregabalin treatment will last 6 weeks.

The clinical treatment centers work as a collaborative research group called the Chronic Prostatitis Collaborative Research Network (CPCRN), which the NIDDK established in 1997. The CPCRN is part of a large, multicenter collaborative of 20 multispecialty clinical centers––the Urologic Pelvic Pain Clinical Research Network—focusing on understanding urologic pelvic pain syndromes in both men and women. A data coordinating center is based at the University of Pennsylvania School of Medicine.

Ongoing Drug Trial

Another CPCRN trial, which began enrolling participants early last year, is studying the effectiveness of 12 weeks of alfuzosin therapy in newly diagnosed CP/CPPS patients. Alfuzosin is an alpha-blocker physicians use primarily to treat symptoms associated with prostate enlargement in older men. Research has shown that alfuzosin may affect both the peripheral and central nervous system’s response to pain. Researchers believed enough evidence existed to study the treatment of alfuzosin in patients with relatively new onset of CP/CPPS.

The enrollment goal for the trial is 280 participants and Nyberg said the study is ahead of its enrollment goal. “Recruitment is going extremely well,” said Nyberg.

Patients eligible for this study differ from the pregabalin study group in that the alfuzosin patients must be newly diagnosed and not have been subjected to long-term multiple treatments. Visit the CPCRN home page for more information about the network.

Editor: Leroy M. Nyberg Jr., Ph.D., M.D.

Dr. Nyberg is the director of urology and urology centers programs at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health (NIH) in Bethesda, Maryland. Dr. Nyberg is a graduate of Tufts University in Boston, Columbia University in New York, and the University of Massachusetts Medical School in Worcester and completed residency training in urology at The Johns Hopkins Hospital in Baltimore. He has also held faculty positions in urology at The Johns Hopkins Medical School, in urology and biochemistry at the Medical University of South Carolina, and in urology at the University of Connecticut. Dr. Nyberg received the Distinguished Service Award from the American Urological Association for significant clinical and research contributions to urology. He also received the NIH Directors Award for excellence for the development of urology research programs at the NIH.

NIH Publication No. 07–5743
November 2006