Conditions: Nocturia Prostatic Hyperplasia
Keywords: nocturia BPH benign prostate hyperplasia nocturia in men with benign prostate hyperplasia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief summary:
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Detailed description:
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: silodosin
Intervention descriptions: intervention 1: α1-adrenergic antagonist

Protocol document: