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

Primary Purpose

BPH

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Alfuzosin
Alfuzosin
Alfuzosin
Alfuzosin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH focused on measuring LUTS, BPH, bladder outlet obstruction, bladder contractility

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    group1

    group2

    group 3

    group 4

    Arm Description

    Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

    BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.

    BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

    BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    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.
    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.
    Changes in Residual Urine Volumes
    Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.

    Full Information

    First Posted
    June 11, 2008
    Last Updated
    February 1, 2021
    Sponsor
    Asan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00696761
    Brief Title
    The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Asan Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BPH
    Keywords
    LUTS, BPH, bladder outlet obstruction, bladder contractility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    232 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group1
    Arm Type
    Active Comparator
    Arm Description
    Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
    Arm Title
    group2
    Arm Type
    Active Comparator
    Arm Description
    BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
    Arm Title
    group 3
    Arm Type
    Active Comparator
    Arm Description
    BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
    Arm Title
    group 4
    Arm Type
    Active Comparator
    Arm Description
    BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
    Intervention Type
    Drug
    Intervention Name(s)
    Alfuzosin
    Other Intervention Name(s)
    xatral
    Intervention Description
    10mg, once daily, 12months
    Intervention Type
    Drug
    Intervention Name(s)
    Alfuzosin
    Other Intervention Name(s)
    xatral
    Intervention Description
    10mg, once daily, 12months
    Intervention Type
    Drug
    Intervention Name(s)
    Alfuzosin
    Other Intervention Name(s)
    xatral
    Intervention Description
    10mg, once daily, 12months
    Intervention Type
    Drug
    Intervention Name(s)
    Alfuzosin
    Other Intervention Name(s)
    xatral
    Intervention Description
    10mg, once daily, 12months
    Primary Outcome Measure Information:
    Title
    Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
    Description
    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
    Time Frame
    12months
    Title
    Treatment Efficacy Was Analyzed by Validated Symptom Scores.
    Description
    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.
    Time Frame
    12 month
    Secondary Outcome Measure Information:
    Title
    Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
    Description
    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.
    Time Frame
    12months
    Title
    Changes of Peak Flow Rates on Uroflowmetry
    Description
    Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
    Time Frame
    12 months
    Title
    Changes in Residual Urine Volumes
    Description
    Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
    Time Frame
    12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Myung-Soo Choo, M.D., PhD
    Organizational Affiliation
    From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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