Trial Outcomes & Findings for The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients (NCT NCT00696761)
NCT ID: NCT00696761
Last Updated: 2021-02-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
232 participants
Primary outcome timeframe
12months
Results posted on
2021-02-17
Participant Flow
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
232 participants recruited; 276 screened, 44 excluded
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
76
|
41
|
54
|
|
Overall Study
COMPLETED
|
41
|
50
|
30
|
44
|
|
Overall Study
NOT COMPLETED
|
20
|
26
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Baseline characteristics by cohort
| Measure |
Group 3
n=41 Participants
BOOI\<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months
|
Group 4
n=54 Participants
BOOI\<20, BCI\<100
alfuzosin : 10mg, once daily, 12 months
|
group1
n=61 Participants
BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months
|
group2
n=76 Participants
BOOI≥ 20, BCI\<100
alfuzosin : 10mg, once daily, 12months
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
192 Participants
n=36 Participants
|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 2.0 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 0 • n=4 Participants
|
66.0 years
STANDARD_DEVIATION 1.2 • n=27 Participants
|
63.1 years
STANDARD_DEVIATION 5 • n=483 Participants
|
65.7 years
STANDARD_DEVIATION 7.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
232 Participants
n=36 Participants
|
|
Region of Enrollment
Korea, Republic of
|
41 participants
n=93 Participants
|
54 participants
n=4 Participants
|
61 participants
n=27 Participants
|
76 participants
n=483 Participants
|
232 participants
n=36 Participants
|
|
international prostate symptom score
|
18.9 scores
STANDARD_DEVIATION 7.6 • n=93 Participants
|
18.8 scores
STANDARD_DEVIATION 6.8 • n=4 Participants
|
19.4 scores
STANDARD_DEVIATION 6.9 • n=27 Participants
|
21.0 scores
STANDARD_DEVIATION 6.5 • n=483 Participants
|
19.5 scores
STANDARD_DEVIATION 6.95 • n=36 Participants
|
PRIMARY outcome
Timeframe: 12monthsinternational 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
Outcome measures
| Measure |
BOOI≥ 20, BCI≥100
n=41 Participants
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
n=50 Participants
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI≥ 100
n=30 Participants
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI<100
n=44 Participants
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months
|
|---|---|---|---|---|
|
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
|
13.0 score
Standard Deviation 6.6
|
12.0 score
Standard Deviation 5.4
|
10.6 score
Standard Deviation 6.1
|
13.4 score
Standard Deviation 6.3
|
PRIMARY outcome
Timeframe: 12 monthPopulation: The population analyzed included participants receiving drug for 12 months
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.
Outcome measures
| Measure |
BOOI≥ 20, BCI≥100
n=30 Participants
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
n=44 Participants
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI≥ 100
n=41 Participants
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI<100
n=50 Participants
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months
|
|---|---|---|---|---|
|
Treatment Efficacy Was Analyzed by Validated Symptom Scores.
|
8.3 score
Standard Deviation 6.2
|
6.4 score
Standard Deviation 6.2
|
6.4 score
Standard Deviation 6.5
|
9.0 score
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 12monthsChanges 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.
Outcome measures
| Measure |
BOOI≥ 20, BCI≥100
n=41 Participants
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
n=50 Participants
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI≥ 100
n=30 Participants
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI<100
n=44 Participants
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months
|
|---|---|---|---|---|
|
Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
|
8.2 score on a scale
Standard Deviation 4.3
|
7.2 score on a scale
Standard Deviation 3.4
|
9.7 score on a scale
Standard Deviation 6.4
|
8.2 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: 12 monthsChanges of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Outcome measures
| Measure |
BOOI≥ 20, BCI≥100
n=41 Participants
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
n=50 Participants
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI≥ 100
n=30 Participants
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI<100
n=44 Participants
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months
|
|---|---|---|---|---|
|
Changes of Peak Flow Rates on Uroflowmetry
|
14.3 ml/s
Standard Deviation 7.2
|
10.9 ml/s
Standard Deviation 6.4
|
16.8 ml/s
Standard Deviation 8.7
|
13.0 ml/s
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 12 monthsChanges in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Outcome measures
| Measure |
BOOI≥ 20, BCI≥100
n=41 Participants
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
n=50 Participants
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI≥ 100
n=30 Participants
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12months
|
BOOI<20, BCI<100
n=44 Participants
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
alfuzosin: 10mg, once daily, 12 months
|
|---|---|---|---|---|
|
Changes in Residual Urine Volumes
|
51.6 ml
Standard Deviation 87
|
37 ml
Standard Deviation 45.2
|
29.3 ml
Standard Deviation 35.9
|
31.7 ml
Standard Deviation 35.3
|
Adverse Events
Group 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
group1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
group2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 3
n=41 participants at risk
BOOI\<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months
|
Group 4
n=54 participants at risk
BOOI\<20, BCI\<100
alfuzosin : 10mg, once daily, 12 months
|
group1
n=61 participants at risk
BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months
|
group2
n=76 participants at risk
BOOI≥ 20, BCI\<100
alfuzosin : 10mg, once daily, 12months
|
|---|---|---|---|---|
|
Vascular disorders
dizziness
|
4.9%
2/41 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
3.9%
3/76 • Number of events 3
|
Additional Information
Kanghyon Song, Myung-Soo Choo, Kyu-Sung Lee, Ji-Yeon Han, Young-Suk Lee,
the Department of Urology, Asan Medical Center, University of Ulsan College
Phone: 82-2-3010-3735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place