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

BPH Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696761
• Other study ID #: L9990
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: August 2008

Study information

• Verified date: February 2021
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BPH
• Urinary Bladder Neck Obstruction

Intervention

Drug:
• Alfuzosin
10mg, once daily, 12months
• Alfuzosin
10mg, once daily, 12months
• Alfuzosin
10mg, once daily, 12months
• Alfuzosin
10mg, once daily, 12months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	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	12months
Primary	Treatment Efficacy Was Analyzed by Validated Symptom Scores.	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.	12 month
Secondary	Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	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.	12months
Secondary	Changes of Peak Flow Rates on Uroflowmetry	Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.	12 months
Secondary	Changes in Residual Urine Volumes	Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.	12 months