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The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.
This study is designed as a multi-center, prospective, open-label and single-arm study. Subjects who are willing to provide written informed consent will be enrolled after screening for eligibility criteria. The subjects will be administered with investigational product for 12 weeks and visit as outpatients for evaluation of safety and efficacy at baseline (visit 2) and 4 weeks (visit 3) and 12 weeks (visit 4) after baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin | Experimental | Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin | Drug |
|
| |
| Laboratory tests |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nocturia | Descriptive statistics for incidence of nocturia will be provided for each visit. Paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in International Prostate Symptom Score(IPSS) from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon St.Mary's Hospital | Bucheon-si | Gyeonggi-do | 420-818 | South Korea | ||
| Ajou University Hospital |
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| Other |
Subject's overall health state will be evaluated by clinical laboratory tests. Serum chemistry test: Creatinine, Blood Urea Nitrogen(BUN), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT) Urinalysis: Urine Specific Gravity, Urine pH, Urine Protein, Urine Glucose, Urine Ketone, Urine Bilirubin, Urine Urobilinogen, Urine Nitrite, Urine Occult Blood(OB), Urine Red Blood Cell(RBC), Urine White Blood Cell(WBC) Immunoassay: Prostate Specific Antigen(PSA) |
|
| 3-days voiding diary | Other | 3-day voiding diaries will be distributed on Visits 1, 2 and 3. Subjects will record incidence of nocturia during 3 days on the diaries within 7 days of Visits 2 (baseline), 3 and 4. The average will be used to confirm the change in incidence of nocturia (at baseline, results from within 1 week from screening may be used but will be excluded for subjects needing wash-out period). |
|
| 12 weeks | Other |
|
| 12 weeks |
| Mean change in Quality of Life(QoL) scores from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Mean change in Overactive Bladder Symptom Score(OABSS) from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline | Descriptive statistics for secondary efficacy outcome measures will be provided for each visit. Assessment will be performed on whether the change from baseline to after 12 weeks of treatment has difference. For successive data, paired t-test or Wilcoxon's signed rank test will be used for assessment of change from baseline to after 12 weeks of treatment. | 12 weeks |
| Ratio of subjects with ≥ 25% decrease in incidence of nocturia | 12 weeks |
| Ratio of subjects with ≥ 25% decrease in IPSS | 12 weeks |
| Suwon |
| Gyeonggi-do |
| 443-380 |
| South Korea |
| Pusan Natonal University Hospital | Busan | 602-739 | South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Hanyang University Hospital | Seoul | 133-792 | South Korea |
| Soon Chun Hyang University Hospital | Seoul | 140-887 | South Korea |
| ID | Term |
|---|---|
| D053158 | Nocturia |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
| D019411 | Clinical Laboratory Techniques |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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