BPH
Conditions
Keywords
LUTS, BPH, bladder outlet obstruction, bladder contractility
Brief summary
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.
Detailed description
1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility 2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity & frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)
Interventions
DRUGAlfuzosin
10mg, once daily, 12months
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH * Patients satisfying all of the following: * Moderate to severe LUTS : * international prostate symptom score (IPSS)≥ 8 * An enlarged prostate (≥25 mL) * Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)
Exclusion criteria
* Post voided residual urine ≥ 200 mL * Patients performing catheterization * Urinary tract infection patients * Patients taking 5 alpha reductase inhibitor * Known hypersensitivity to alfuzosin * History of postural hypotension or syncope * Hypertension patients treated with other alpha1-blockers * Patients newly taking anticholinergic medication within 1 month * Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range) * Renal insufficiency (s-Cr ≥ 2mg/dL) * Unstable angina pectoris * Uninvestigated hematuria * Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included) * Interstitial cystitis patients * Severe concomitant condition threatening life. * Patient who is unable to make voiding diary * Bladder or prostate cancer patients * Patients receiving prostate or bladder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 12months | 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 |
| Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 12 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 12months | 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. |
| Changes of Peak Flow Rates on Uroflowmetry | 12 months | Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment. |
| Changes in Residual Urine Volumes | 12 months | Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment. |
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Group 3 BOOI\<20, BCI≥ 100)
alfuzosin : 10mg, once daily, 12months | 41 |
| Group 4 BOOI\<20, BCI\<100
alfuzosin : 10mg, once daily, 12 months | 54 |
| group1 BOOI≥ 20, BCI≥ 100
alfuzosin : 10mg, once daily, 12months | 61 |
| group2 BOOI≥ 20, BCI\<100
alfuzosin : 10mg, once daily, 12months | 76 |
| Total | 232 |
Baseline characteristics
| Characteristic | Group 3 | Group 4 | group1 | group2 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 44 Participants | 51 Participants | 66 Participants | 192 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Age, Continuous | 67.0 years STANDARD_DEVIATION 2 | 67.4 years STANDARD_DEVIATION 0 | 66.0 years STANDARD_DEVIATION 1.2 | 63.1 years STANDARD_DEVIATION 5 | 65.7 years STANDARD_DEVIATION 7.3 |
| international prostate symptom score | 18.9 scores STANDARD_DEVIATION 7.6 | 18.8 scores STANDARD_DEVIATION 6.8 | 19.4 scores STANDARD_DEVIATION 6.9 | 21.0 scores STANDARD_DEVIATION 6.5 | 19.5 scores STANDARD_DEVIATION 6.95 |
| Region of Enrollment Korea, Republic of | 41 participants | 54 participants | 61 participants | 76 participants | 232 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 54 Participants | 61 Participants | 76 Participants | 232 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 41 | 2 / 54 | 2 / 61 | 3 / 76 |
| serious Total, serious adverse events | 0 / 41 | 0 / 54 | 0 / 61 | 0 / 76 |
Outcome results
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
Time frame: 12months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOOI≥ 20, BCI≥100 | Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 13.0 score | Standard Deviation 6.6 |
| BOOI≥ 20, BCI<100 | Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 12.0 score | Standard Deviation 5.4 |
| BOOI<20, BCI≥ 100 | Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 10.6 score | Standard Deviation 6.1 |
| BOOI<20, BCI<100 | Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment | 13.4 score | Standard Deviation 6.3 |
p-value: <0.05Kruskal-Wallis
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.
Time frame: 12 month
Population: The population analyzed included participants receiving drug for 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOOI≥ 20, BCI≥100 | Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 8.3 score | Standard Deviation 6.2 |
| BOOI≥ 20, BCI<100 | Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 6.4 score | Standard Deviation 6.2 |
| BOOI<20, BCI≥ 100 | Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 6.4 score | Standard Deviation 6.5 |
| BOOI<20, BCI<100 | Treatment Efficacy Was Analyzed by Validated Symptom Scores. | 9.0 score | Standard Deviation 6.1 |
Comparison: 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.p-value: <0.05Kruskal-Wallis
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOOI≥ 20, BCI≥100 | Changes in Residual Urine Volumes | 51.6 ml | Standard Deviation 87 |
| BOOI≥ 20, BCI<100 | Changes in Residual Urine Volumes | 37 ml | Standard Deviation 45.2 |
| BOOI<20, BCI≥ 100 | Changes in Residual Urine Volumes | 29.3 ml | Standard Deviation 35.9 |
| BOOI<20, BCI<100 | Changes in Residual Urine Volumes | 31.7 ml | Standard Deviation 35.3 |
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.
Time frame: 12months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOOI≥ 20, BCI≥100 | Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 8.2 score on a scale | Standard Deviation 4.3 |
| BOOI≥ 20, BCI<100 | Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 7.2 score on a scale | Standard Deviation 3.4 |
| BOOI<20, BCI≥ 100 | Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 9.7 score on a scale | Standard Deviation 6.4 |
| BOOI<20, BCI<100 | Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) | 8.2 score on a scale | Standard Deviation 4.1 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BOOI≥ 20, BCI≥100 | Changes of Peak Flow Rates on Uroflowmetry | 14.3 ml/s | Standard Deviation 7.2 |
| BOOI≥ 20, BCI<100 | Changes of Peak Flow Rates on Uroflowmetry | 10.9 ml/s | Standard Deviation 6.4 |
| BOOI<20, BCI≥ 100 | Changes of Peak Flow Rates on Uroflowmetry | 16.8 ml/s | Standard Deviation 8.7 |
| BOOI<20, BCI<100 | Changes of Peak Flow Rates on Uroflowmetry | 13.0 ml/s | Standard Deviation 5.3 |