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

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ClinicalTrials.gov Identifier: NCT00696761
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : March 4, 2014
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition BPH
Intervention Drug: alfuzosin
Enrollment 232
Recruitment Details Participants recruited from a specialty clinic at the Asan Medical Center, Samsung Medical Center,The Catholic University of Korea College of Medicine, Hallym University, Chuncheon, Korea for 12-month
Pre-assignment Details 232 participants recruited; 276 screened, 44 excluded
Arm/Group Title BOOI≥20, BCI≥ 100 BOOI≥20, BCI< 100 BOOI<20, BCI≥ 100 BOOI<20, BCI< 100
Hide Arm/Group Description

Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100

alfuzosin : 10mg, once daily, 12months

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months

Period Title: Overall Study
Started 61 76 41 54
Completed 41 50 30 44
Not Completed 20 26 11 10
Arm/Group Title Group 3 Group 4 group1 group2 Total
Hide Arm/Group Description

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months

BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

Total of all reporting groups
Overall Number of Baseline Participants 41 54 61 76 232
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 54 participants 61 participants 76 participants 232 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  24.4%
10
  18.5%
10
  16.4%
10
  13.2%
40
  17.2%
>=65 years
31
  75.6%
44
  81.5%
51
  83.6%
66
  86.8%
192
  82.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 54 participants 61 participants 76 participants 232 participants
67.0  (2.0) 67.4  (0) 66.0  (1.2) 63.1  (5) 65.7  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 54 participants 61 participants 76 participants 232 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
41
 100.0%
54
 100.0%
61
 100.0%
76
 100.0%
232
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 41 participants 54 participants 61 participants 76 participants 232 participants
41 54 61 76 232
international prostate symptom score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores
Number Analyzed 41 participants 54 participants 61 participants 76 participants 232 participants
18.9  (7.6) 18.8  (6.8) 19.4  (6.9) 21.0  (6.5) 19.5  (6.95)
[1]
Measure Description: higher values represent a worse outcome total score range (form 0 to 35)
1.Primary Outcome
Title Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BOOI≥ 20, BCI≥100 BOOI≥ 20, BCI<100 BOOI<20, BCI≥ 100 BOOI<20, BCI<100
Hide Arm/Group Description:

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

alfuzosin: 10mg, once daily, 12months

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

alfuzosin: 10mg, once daily, 12months

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

alfuzosin: 10mg, once daily, 12months

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

alfuzosin: 10mg, once daily, 12 months

Overall Number of Participants Analyzed 41 50 30 44
Mean (Standard Deviation)
Unit of Measure: score
13.0  (6.6) 12.0  (5.4) 10.6  (6.1) 13.4  (6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BOOI≥ 20, BCI≥100, BOOI≥ 20, BCI<100, BOOI<20, BCI≥ 100, BOOI<20, BCI<100
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Primary Outcome
Title Treatment Efficacy Was Analyzed by Validated Symptom Scores.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included participants receiving drug for 12 months
Arm/Group Title Group 3 Group 4 group1 group2
Hide Arm/Group Description:

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months

BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

Overall Number of Participants Analyzed 30 44 41 50
Mean (Standard Deviation)
Unit of Measure: score
8.3  (6.2) 6.4  (6.2) 6.4  (6.5) 9.0  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 3, Group 4, group1, group2
Comments The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement
Hide Description [Not Specified]
Time Frame 3month, 6month, 12month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 3 Group 4 group1 group2
Hide Arm/Group Description

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months

BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

All-Cause Mortality
Group 3 Group 4 group1 group2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 3 Group 4 group1 group2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/54 (0.00%)      0/61 (0.00%)      0/76 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.9%
Group 3 Group 4 group1 group2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/41 (4.88%)      2/54 (3.70%)      2/61 (3.28%)      3/76 (3.95%)    
Vascular disorders         
dizziness   2/41 (4.88%)  2 2/54 (3.70%)  2 2/61 (3.28%)  2 3/76 (3.95%)  3
Indicates events were collected by systematic assessment
Patients were not divided into three groups according to the ICS nomogram (obstructed [BOOI <40], equivocally obstructed (20 <BOOI <40), and unobstructed [BOOI <20]).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kanghyon Song, Myung-Soo Choo, Kyu-Sung Lee, Ji-Yeon Han, Young-Suk Lee,
Organization: the Department of Urology, Asan Medical Center, University of Ulsan College
Phone: 82-2-3010-3735
EMail: mschoo@amc.seoul.kr
Layout table for additonal information
Responsible Party: Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00696761     History of Changes
Other Study ID Numbers: L9990
First Submitted: June 11, 2008
First Posted: June 13, 2008
Results First Submitted: July 22, 2013
Results First Posted: March 4, 2014
Last Update Posted: February 12, 2018