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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group1 | Active Comparator | Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. |
|
| group2 | Active Comparator | BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. |
|
| group 3 | Active Comparator | BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. |
|
| group 4 | Active Comparator | BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfuzosin | Drug | 10mg, once daily, 12months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12months |
| 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. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12months |
| Changes of Peak Flow Rates on Uroflowmetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung-Soo Choo, M.D., PhD | From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea | Principal Investigator |
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232 participants recruited; 276 screened, 44 excluded
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
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| ID | Title | Description |
|---|---|---|
| FG000 | BOOI≥20, BCI≥ 100 | Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100 alfuzosin : 10mg, once daily, 12months |
| FG001 | BOOI≥20, BCI< 100 | BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months |
| FG002 | BOOI<20, BCI≥ 100 | BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months |
| FG003 | BOOI<20, BCI< 100 | BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 3 | BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months |
| BG001 | Group 4 | BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score | 12months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3 | BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Vascular disorders | Systematic Assessment |
Patients were not divided into three groups according to the ICS nomogram (obstructed [BOOI <40], equivocally obstructed (20 \
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | 82-2-3010-3735 | mschoo@amc.seoul.kr |
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| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C047638 | alfuzosin |
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| Alfuzosin | Drug | 10mg, once daily, 12months |
|
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| Alfuzosin | Drug | 10mg, once daily, 12months |
|
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| Alfuzosin | Drug | 10mg, once daily, 12months |
|
|
Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment. |
| 12 months |
| Changes in Residual Urine Volumes | Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment. | 12 months |
| BG002 | group1 | BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months |
| BG003 | group2 | BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| international prostate symptom score | higher values represent a worse outcome total score range (form 0 to 35) | Mean | Standard Deviation | scores |
|
| OG002 | BOOI<20, BCI≥ 100 | BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12months |
| OG003 | BOOI<20, BCI<100 | BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12 months |
|
|
|
| Primary | 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. | The population analyzed included participants receiving drug for 12 months | Posted | Mean | Standard Deviation | score | 12 month |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ml/s | 12 months |
|
|
|
| Secondary | Changes in Residual Urine Volumes | Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment. | Posted | Mean | Standard Deviation | ml | 12 months |
|
|
|
| 0 |
| 41 |
| 2 |
| 41 |
| EG001 | Group 4 | BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months | 0 | 54 | 2 | 54 |
| EG002 | group1 | BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months | 0 | 61 | 2 | 61 |
| EG003 | group2 | BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months | 0 | 76 | 3 | 76 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |