Conditions: Prostatitis
Keywords: Prostatitis Non-bacterial Prostatitis Prostatodynia Alfuzosin Alpha-adrenergic blocker
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 272
Healthy volunteers: no

Brief summary:
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Detailed description:
The two primary objectives of this study are:

* To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
* To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization.

There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

Arms:
arm 1: 10 mg of alfuzosin once daily for 12 weeks arm 2: 10 mg of an identical-looking placebo once daily for 12 weeks

Interventions: intervention 1: Alfuzosin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: