CompletedPhase 3

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

United States, Canada272 participantsStarted 2005-02

Plain-language 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

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant has signed and dated the appropriate Informed Consent document. * Participant is male. * Participant is at least 18 years of age. * Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation. * Symptoms bothersome enough to prompt a physician visit have been present for two years or less. Exclusion Criteria: * Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2). * Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason. * Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy. * Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders. * Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder. * Participant has uninvestigated, significant he…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks

Timeframe: Baseline and 12 weeks

Trial details

NCT IDNCT00103402

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2008-01

Results submitted2018-03-23

View on ClinicalTrials.gov More Prostatitis trials