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

February 1, 2021 updated by: Myung-Soo Choo, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group1
Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
10mg, once daily, 12months
Other Names:
  • xatral
Active Comparator: group2
BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
10mg, once daily, 12months
Other Names:
  • xatral
Active Comparator: group 3
BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
10mg, once daily, 12months
Other Names:
  • xatral
Active Comparator: group 4
BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
10mg, once daily, 12months
Other Names:
  • xatral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
Time Frame: 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
12months
Treatment Efficacy Was Analyzed by Validated Symptom Scores.
Time Frame: 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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
Time Frame: 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.
12months
Changes of Peak Flow Rates on Uroflowmetry
Time Frame: 12 months
Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
12 months
Changes in Residual Urine Volumes
Time Frame: 12 months
Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Myung-Soo Choo, M.D., PhD, From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 13, 2008

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L9990

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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