What are the factors contributing to failure in improvement of subjective symptoms following silodosin administration in patients with benign prostatic hyperplasia? Investigation using a pressure-flow study.

UMIN ID: UMIN000019289

Registered date:09/10/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Benign prostate hyperplasia
• Date of first enrollment: 2009/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): a silodosin capsule 4 mg twice daily (8 mg/day) for 4 weeks

Outcome(s)

• Primary Outcome: To compare patient background and objective findings from PFS performed at baseline and post-treatment between good and poor responders in symptom improvement.

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: Patients currently receiving alpha-blockers, anticholinergic drugs, antidepressants, antianxiety drugs and/or sex hormones, those with suspected prostate cancer, neurovesical dysfunction, bladder stone or active urinary tract infection were excluded. Patients with any serious cardiac complication, renal complication (serum creatinine of 2 mg/dl or greater) or hepatic complication (AST and ALT that are at least double the reference values) were also excluded.

Related Information

• Primary Sponsor: Department of Urology Nagoya University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Urology Nagoya University Graduate School of Medicine