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

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: BPH

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00696761

L9990

Details and patient eligibility

About

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.

Full 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)

Enrollment: 232 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 4 patient groups

group1

Active Comparator group

Description:

Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

Treatment:

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

group2

Active Comparator group

Description:

BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Treatment:

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

group 3

Active Comparator group

Description:

BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

Treatment:

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

group 4

Active Comparator group

Description:

BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Treatment:

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin

Drug: Alfuzosin