CompletedPhase 4

The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients

232 participantsStarted 2006-05

Plain-language summary

Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines. It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

Who can participate

Age range50 Years

SexMALE

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

Inclusion Criteria: * Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH * Patients satisfying all of the following: * Moderate to severe LUTS : * international prostate symptom score (IPSS)≥ 8 * An enlarged prostate (≥25 mL) * Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL) Exclusion Criteria: * Post voided residual urine ≥ 200 mL * Patients performing catheterization * Urinary tract infection patients * Patients taking 5 alpha reductase inhibitor * Known hypersensitivity to alfuzosin * History of postural hypotension or syncope * Hypertension patients treated with other alpha1-blockers * Patients newly taking anticholinergic medication within 1 month * Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range) * Renal insufficiency (s-Cr ≥ 2mg/dL) * Unstable angina pectoris * Uninvestigated hematuria * Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included) * Interstitial cystitis patients * Severe concomitant condition threatening life. * Patient who is unable to make voiding diary * Bladder or prostate cancer patients * Patients receiving prostate or bladder surgery

What they're measuring

Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment

Timeframe: 12months

Treatment Efficacy Was Analyzed by Validated Symptom Scores.

Timeframe: 12 month

Trial details

NCT IDNCT00696761

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2013-07-22