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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00696761
First received: June 11, 2008
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
BPH
Drug: alfuzosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment [ Time Frame: 12months ] [ Designated as safety issue: No ]

    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. [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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:
  • Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement [ Time Frame: 3month, 6month, 12month ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: May 2006
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: xatral
Active Comparator: group2
BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: alfuzosin
10mg, once daily, 12months
Other Name: 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 Name: xatral
Active Comparator: group 4
BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: alfuzosin
10mg, once daily, 12 months
Other Name: xatral

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696761

Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Myung-Soo Choo, urology department, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00696761     History of Changes
Other Study ID Numbers: L9990
Study First Received: June 11, 2008
Results First Received: July 22, 2013
Last Updated: January 15, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
LUTS
BPH
bladder outlet obstruction
bladder contractility

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urinary Bladder Neck Obstruction
Urological Manifestations
Signs and Symptoms
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014