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

Phase 4

Completed

• Conditions: BPH
• Interventions: Drug: Alfuzosin

• Registration Number: NCT00696761
• Lead Sponsor: Asan Medical Center

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)

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Results First Submitted: 2013-07-22
• Results First Submitted QC: 2014-01-15
• Results First Posted: 2014-03-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 3	Alfuzosin	BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
group1	Alfuzosin	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
group2	Alfuzosin	BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
group 4	Alfuzosin	BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Primary Outcome Measures

Name	Time	Method
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	12months	international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome; Baseline score minus 12-month score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.	12 month	Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.

Secondary Outcome Measures

Name	Time	Method
Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	12months	Changes of International Continence Society (ICS)-male questionnaire (voiding sum) to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.; Range 0-20, higher scores represent worse outcomes.
Changes of Peak Flow Rates on Uroflowmetry	12 months	Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Changes in Residual Urine Volumes	12 months	Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.