Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 11, 2008
January 15, 2014
May 2006
July 2008   (final data collection date for primary outcome measure)
  • 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.
Primary outcome; IPSS changes between 4 groups compared to baseline after 12 mo treatment [ Time Frame: 12months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00696761 on ClinicalTrials.gov Archive Site
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 ]
Changes of ICS-male questionnaire, uroflowmetry, residual urine volume, and Patient's Global Impression of Improvement [ Time Frame: 3month, 6month, 12month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
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.

  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)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
BPH
  • Drug: alfuzosin
    10mg, once daily, 12months
    Other Name: xatral
  • Drug: alfuzosin
    10mg, once daily, 12 months
    Other Name: xatral
  • Active Comparator: group1
    Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
    Intervention: Drug: alfuzosin
  • Active Comparator: group2
    BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
    Intervention: Drug: alfuzosin
  • Active Comparator: group 3
    BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
    Intervention: Drug: alfuzosin
  • Active Comparator: group 4
    BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
    Intervention: Drug: alfuzosin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
August 2008
July 2008   (final data collection date for primary outcome measure)

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
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00696761
L9990
No
Myung-Soo Choo, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Myung-Soo Choo, M.D., PhD From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Asan Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP