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
About this trial
This is an interventional treatment trial for BPH focused on measuring LUTS, BPH, bladder outlet obstruction, bladder contractility
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
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
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
We'll reach out to this number within 24 hrs