A Phase 4 interventional study of Alfuzosin and Alfuzosin in BPH, sponsored by Asan Medical Center. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Asan Medical Center · Phase 4, Interventional, and Treatment
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.
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 232 is above the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
Drug: Alfuzosin
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
Time frame: 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.
Time frame: 12 month
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.
Time frame: 12months
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.
Time frame: 12 months
Changes in Residual Urine Volumes
Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Time frame: 12 months
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
| Milestone | 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 |
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
| score | BOOI≥ 20, BCI≥100 | BOOI≥ 20, BCI<100 | BOOI<20, BCI≥ 100 | BOOI<20, BCI<100 |
|---|---|---|---|---|
| Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 13.0 ± 6.6 | 12.0 ± 5.4 | 10.6 ± 6.1 | 13.4 ± 6.3 |
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.
| score | Group 3 | Group 4 | group1 | group2 |
|---|---|---|---|---|
| Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 8.3 ± 6.2 | 6.4 ± 6.2 | 6.4 ± 6.5 | 9.0 ± 6.1 |
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.
| score on a scale | group1 | group2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 8.2 ± 4.3 | 7.2 ± 3.4 | 9.7 ± 6.4 | 8.2 ± 4.1 |
Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
| ml/s | group1 | group2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Changes of Peak Flow Rates on Uroflowmetry | 14.3 ± 7.2 | 10.9 ± 6.4 | 16.8 ± 8.7 | 13.0 ± 5.3 |
Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
| ml | group1 | group2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Changes in Residual Urine Volumes | 51.6 ± 87 | 37 ± 45.2 | 29.3 ± 35.9 | 31.7 ± 35.3 |
Non-serious events are listed at a 3.9% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 3 | — | 0/41 (0%) | 2/41 (4.9%) |
| Group 4 | — | 0/54 (0%) | 2/54 (3.7%) |
| group1 | — | 0/61 (0%) | 2/61 (3.3%) |
| group2 | — | 0/76 (0%) | 3/76 (3.9%) |
| Event | Group 3 | Group 4 | group1 | group2 |
|---|---|---|---|---|
| dizzinessVascular disorders | 2/41 | 2/54 | 2/61 | 3/76 |
| Age, Categorical(Participants) | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| <=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, Continuous(years) | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| Mean | 67.0 ± 2.0 | 67.4 ± 0 | 66.0 ± 1.2 | 63.1 ± 5 | 65.7 ± 7.3 |
| Sex: Female, Male(Participants) | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 41 | 54 | 61 | 76 | 232 |
| Region of Enrollment(participants) | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| Korea, Republic of | 41 | 54 | 61 | 76 | 232 |
| international prostate symptom score(scores) | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| Mean | 18.9 ± 7.6 | 18.8 ± 6.8 | 19.4 ± 6.9 | 21.0 ± 6.5 | 19.5 ± 6.95 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alfuzosin
Urinary Bladder Neck Obstruction →