The efficacy and safety of silodosin on nocturia for patients with benign prostatic hyperplasia
Not Applicable
Completed
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003797
- Lead Sponsor
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 126
Inclusion Criteria
nocturia (=2 events/night) on 3-day voiding diary, an International Prostate Symptom Score (IPSS) =8, and a quality of life score =3
Exclusion Criteria
prostate specific antigen >10 ng/ml, neurogenic bladder, bladder cancer, bladder stones, urethral stricture, acute urinary retention, urinary tract infection within one month, prostate cancer, a history of prostate surgery, use of an a-blocker or antimuscarinic agents within 2 weeks, or use of 5-a-reductase inhibitors within 6 months
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change in the mean number of nocturia episodes in a voiding diary from the baseline to the final assessment
- Secondary Outcome Measures
Name Time Method changes in IPSS total score;changes in IPSS quality of life score;changes in overactive bladder symptom score;changes in International Consultation on Incontinence Questionnaire-Nocturia score;percentage of patients with 25% or more IPSS reduction rate after 12 weeks of treatment;percentage of patients with 25% or more nocturia reduction after 12 weeks of treatment