Chronic Prostatitis Collaborative Research Network Clinical Trial - Alfuzosin (CPCRN2 RCT#1)

General Description

The second phase of the Chronic Prostatitis Collaborative Research Network (CPCRN chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) was established to conducted randomized clinical trials of promising therapies for this syndrome. In men with CP/CPPS , treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. In response to the findings of these previous trials, the CPCRN conducted a multicenter, randomized, placebo-controlled trial of alfuzosin to determine whether the symptoms CP/CPPS could be reduced in men who had recently received a diagnosis of CP/CPPS and who had not previously been treated with this class of drug.

Men with CP/CPPS were enrolled at 11 recruitment centers and randomly assigned in a 1:1 ratio to receive either 10 mg of alfuzosin or placebo once daily for 12 weeks. The trial was double-blind. There were four research-clinic visits during which data for the primary and secondary outcome measures were collected. The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least 4 points from baseline to 12 weeks, which is the minimal clinically significant difference in the score. Secondary outcome measures included evaluations of pain, urinary urgency, medical outcomes, mental health, and erectile dysfunction. Adverse events associated with treatment was assessed for each subject both overall and within each body system.

Results showed no difference between the placebo and the alfuzosin groups in the proportion of men with in an improvement of the NIH-CPSI score and a clinically meaningful reduction of symptoms. Similarly, there was no significant difference between the alfuzosin and placebo groups in multiple secondary outcomes, including the results of the global response assessment and measures of quality of life, depression, sexual function, and pain. These findings do not support the use of alfuzosin to reduce the symptoms of CP/CPPS in men who have not received prior treatment with an alpha-blocker.

Objectives

The primary aim of the study was to evaluate the efficacy and safety of the alpha-adrenergic blocker Alfuzosin (Uroxatral) in men who had recently received a diagnosis of CP/CPPS and who had not previously been treated with this class of drug.

Outcome Measure

The primary outcome measure was a decrease (improvement) in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) of at least 4 points from baseline to 12 weeks, which is the minimal clinically significant difference in the score.

Secondary outcome measures included assessment of general pain and urinary urgency on a Likert scale and the McGill Pain Questionnaire; the Medical Outcomes Study Short Form Health Survey; the Hospital Anxiety and Depression Scale; the International Index of Erectile Function; and the Male Sexual Health Questionnaire. Toxicity was assessed for each subject both overall and within each body system.

Criteria

Men of at least 18 years of age who exhibited: (1) symptoms bothersome enough to prompt a physician visit within the previous two years, (2) symptoms of pain or discomfort in the pelvic region for at least 6 weeks, and (3) a total score of at least 12 on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) were eligible for the study.
Exclusion criteria are documented in the study protocol.

Outcome

The study found no difference between placebo and alfuzosin in the proportion of men with an improvement of at least four points in the NIH-CPSI score. Similarly, there was no significant difference between the alfuzosin and placebo groups in multiple secondary outcomes, including the results of the global response assessment and measures of quality of life, depression, sexual function, and pain. These findings do not support the use of alfuzosin to reduce the symptoms of CP/CPPS in men who have not received prior treatment with an alpha-blocker.