Chronic Prostatitis Collaborative Research Network Clinical Trial- Pregabalin

The Chronic Prostatitis Collaborative Research Network (CPCRN) was established to conduct randomized controlled clinical trials of promising therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in order to treatment of this syndrome. While the pathogenesis of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is not known, there is some evidence to suggest that the urogenital pain of CP/CPPS may be neuropathic. The CPCRN conducted a randomized clinical trial to investigate whether a drug found to be effective for treating neuropathic pain, pregabalin, could be beneficial in treating the symptoms of CP/CPPS.

Men with CP/CPPS form 10 clinical centers were enrolled and randomly assigned 2:1 in each clinical site to receive treatment with either pregabalin or matching placebo (the trial was double-blind). Treatment was for six weeks. Dose was escalated from 150 mg/d (50 mg orally 3 times daily) for 2 weeks, to 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then to 600 mg/d (200 mg orally 3 times daily) for 2 weeks; participants in the placebo group underwent a similar dose escalation. The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. Several secondary outcome measures were assessed, including the subscores of the NIH-CPSI, the Global Response Assessment (a self-reported assessment that measures perception of change in symptoms), the Medical Outcomes Study 12-Item Short Form Health Survey, the Hospital Anxiety and Depression Scale, and the Sexual Health Inventory for Men.

The study found no a clinically significant (6-point) decrease in the NIH-CPSI in men treated with pregabalin compared to those assigned to placebo.