Clinical Trial: Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Multicenter Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of 10mg Alfuzosin in the Treatment of Chronic Prostatitis / Chronic Pelvic Pain Sy

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 Summary:

The two primary objectives of this study are:

  • To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naïve CP/CPPS participants with respect to the primary endpoint in the 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 clinic visits.


Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: NIH-CPSI Total Score

Original Primary Outcome: 4-point decrease from baseline to 12 weeks in the NIH-CPSI Total Score

Current Secondary Outcome:

  • Subscales of the NIH-CPSI
  • Symptom Assessment Form
  • Global Response Assessment
  • McGill Pain Questionnaire
  • Medical Outcomes Study Short Form 12
  • Hospital Anxiety and Depression Scale
  • International Index of Erectile Dysfunction
  • Male Sexual Health Questionnaire


Original Secondary Outcome: Same as current

Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dates:
Date Received: February 7, 2005
Date Started: February 2005
Date Completion:
Last Updated: April 25, 2011
Last Verified: April 2011