Clinical trial NCT00696761: The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Official title: The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: BPH
Keywords: LUTS
BPH
bladder outlet obstruction
bladder contractility
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 232
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
timeFrame: 12months
measure: Treatment Efficacy Was Analyzed by Validated Symptom Scores.
timeFrame: 12 month
Secondary outcomes:
measure: Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
timeFrame: 12months
measure: Changes of Peak Flow Rates on Uroflowmetry
timeFrame: 12 months
measure: Changes in Residual Urine Volumes
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
name: Myung-Soo Choo, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: