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
Results First Received: July 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: BPH
Intervention: Drug: alfuzosin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
232 participants recruited; 276 screened, 44 excluded

Reporting Groups
  Description
BOOI≥20, BCI≥ 100

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

alfuzosin : 10mg, once daily, 12months

BOOI≥20, BCI< 100

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI≥ 100

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

BOOI<20, BCI< 100

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months


Participant Flow:   Overall Study
    BOOI≥20, BCI≥ 100     BOOI≥20, BCI< 100     BOOI<20, BCI≥ 100     BOOI<20, BCI< 100  
STARTED     61     76     41     54  
COMPLETED     41     50     30     44  
NOT COMPLETED     20     26     11     10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 3

BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months

Group 4

BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months

group1

BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months

group2

BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months

Total Total of all reporting groups

Baseline Measures
    Group 3     Group 4     group1     group2     Total  
Number of Participants  
[units: participants]
  41     54     61     76     232  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     10     10     10     40  
>=65 years     31     44     51     66     192  
Age  
[units: years]
Mean ± Standard Deviation
  67.0  ± 2.0     67.4  ± 0     66.0  ± 1.2     63.1  ± 5     65.7  ± 7.3  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     41     54     61     76     232  
Region of Enrollment  
[units: participants]
         
Korea, Republic of     41     54     61     76     232  
international prostate symptom score [1]
[units: scores]
Mean ± Standard Deviation
  18.9  ± 7.6     18.8  ± 6.8     19.4  ± 6.9     21.0  ± 6.5     19.5  ± 6.95  
[1] higher values represent a worse outcome total score range (form 0 to 35)



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment   [ Time Frame: 12months ]

2.  Primary:   Treatment Efficacy Was Analyzed by Validated Symptom Scores.   [ Time Frame: 12 month ]

3.  Secondary:   Changes of International Continence Society (ICS)-Male Questionnaire, Uroflowmetry, Residual Urine Volume, and Patient's Global Impression of Improvement   [ Time Frame: 3month, 6month, 12month ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients were not divided into three groups according to the ICS nomogram (obstructed [BOOI <40], equivocally obstructed (20 <BOOI <40), and unobstructed [BOOI <20]).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
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
e-mail: mschoo@amc.seoul.kr


No publications provided


Responsible Party: Myung-Soo Choo, 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