At a glance
ClinicalIndex Comparison Record- ✓Male participant aged at least 18 years
- ✓At least 6 weeks of pelvic discomfort or pain at presentation
- ✓Symptoms bothersome enough to prompt physician visit present for 2 years or less
- ✓Signed informed consent document
- ✕Prior alpha-blocker therapy (alfuzosin, tamsulosin, doxazosin, terazosin, or other) for CP/CPPS symptoms or within past 2 years for any reason
- ✕History of prostate, penile, testicular, bladder, or urethral cancer or prior pelvic radiation, systemic chemotherapy, or intravesical chemotherapy
- ✕Moderate or severe hepatic impairment, severe renal insufficiency, or severe/unstable cardiovascular, respiratory, hematological, endocrinological, or neurological disorders
- ✕Unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease affecting bladder function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS) in Recently-Diagnosed and/or Newly-Symptomatic Alpha-blocker Naïve Patients
In Brief
A Phase 3 clinical trial evaluating Alfuzosin and Placebo for Prostatitis. Completed, enrolled 272 participants across 10 sites in 2 countries.
Detailed 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