Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
- Conditions
- NocturiaBenign Prostatic Hyperplasia
- Interventions
- Registration Number
- NCT02106182
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 135
- Males of at least 50 years of age, with current diagnosis of benign prostatic hyperplasia
- Symptoms of nocturia evidenced by ≥2 episodes per night in average according to 3-day voiding diary
- More than total of 8 points on IPSS and 3 points on QoL
- Able to provide written informed consent and to comply with all study procedures
- PSA level > 10 ng/㎖ (except patients who had 4 ng/㎖ < PSA level ≤ 10 ng/㎖ 6 months prior to screening and identified as negative from biopsy)
- Symptoms of postural hypotension
- Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
- Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
- Severe cardiac disorders or development or diagnosis of vascular disorder (unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, coronary artery bypass graft, etc) 6 months prior to enrollment
- Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
- Patients with bladder cancer, cystolith or urethral stricture
- Patients with neurogenic bladder
- History of acute urinary retention
- Indwelling catheter or self intermittent catheterization
- Patients with pyuria 1 month prior to screening
- History of prostatic cancer
- History of prostatic surgery
- Patients with uncontrolled chronic disease
- Alcoholism or sustained drug dependent abuse 1 year prior to screening
- Hypersensitivity to α1A-receptor blockers
- Administration of following drugs within according periods prior to screening - 2 weeks: Antimuscarinic agents (Tolterodine, Trospium, Solifenacin, Fesoterodine, Propiverine, Oxybutynin, Flavoxate, etc), Anticholinesterase agents (Neostigmine methylsulfate, etc), Cholinergic agonists (Bethanechol Cl, etc), Benign prostatic hyperplasia agents (Tamsulosin HCl, Prazosin HCl, Terazosin HCl, Doxazosin mesylate, Silodosin, Naftopidil, etc), Tricyclic antidepressants (Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Quinupramine, etc), 6 months: 5-α-Reductase Inhibitors (Finasteride, Dutasteride)
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Silodosin Silodosin Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks Silodosin Laboratory tests Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks Silodosin 3-days voiding diary Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks Silodosin 12 weeks Silodosin, 8 mg, once daily, orally administered with dinner for 12 weeks
- Primary Outcome Measures
Name Time Method Incidence of nocturia 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Mean change in International Prostate Symptom Score(IPSS) from baseline 12 weeks 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.
Mean change in International Consultation on Incontinence modular Questionnaire-Nocturia(ICIQ-N) from baseline 12 weeks 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.
Mean change in Quality of Life(QoL) scores from baseline 12 weeks 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.
Mean change in Overactive Bladder Symptom Score(OABSS) from baseline 12 weeks 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.
Ratio of subjects with ≥ 25% decrease in IPSS 12 weeks Mean change in Questions 3, 5 and 6 (voiding symptoms) of IPSS from baseline 12 weeks 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.
Mean change in Question 1 (postvoiding symptoms) of IPSS from baseline 12 weeks 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.
Mean change in Questions 2, 4 and 7 (storage symptoms) from baseline 12 weeks 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.
Ratio of subjects with ≥ 25% decrease in incidence of nocturia 12 weeks
Trial Locations
- Locations (6)
Bucheon St.Mary's Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Pusan Natonal University Hospital
🇰🇷Busan, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of