The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: BPH
Intervention: alfuzosin (Drug); alfuzosin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Asan Medical Center
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Primary outcome; IPSS changes between 4 groups compared to baseline after 12 mo treatment
Secondary outcome: Changes of ICS-male questionnaire, uroflowmetry, residual urine volume, and Patient's Global Impression of Improvement
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
- Patients satisfying all of the following:
- Moderate to severe LUTS :
- IPSS ≥ 8
- An enlarged prostate (≥25 mL)
- Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)
Exclusion Criteria:
- Post voided residual urine ≥ 200mL
- 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 (AST/ALT ≥ 2 times of normal range)
- Renal insufficiency (s-Cr ≥ 2mg/dL)
- Unstable angina pectoris
- Uninvestigated hematuria
- Serum PSA ≥ 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
Locations and Contacts
Additional Information
Starting date: May 2006
Last updated: June 12, 2008
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