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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.

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. - Factors contributing to a failure in subjective improvement following alpha-blocker administration

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019289
Enrollment
100
Registered
2015-10-09
Start date
2009-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostate hyperplasia

Interventions

a silodosin capsule 4 mg twice daily (8 mg/day) for 4 weeks

Sponsors

Department of Urology Nagoya University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) an IPSS total score of 8 or greater; 2) an IPSS-quality of life (QOL) score of 3 or greater; 3) prostate volume measured by transabdominal or transrectal echography of 20 mL or greater; 4) maximum flow rate (Qmax) by uroflowmetry (UFM) of less than 15 mL/sec at a voiding volume of greater than 100 mL; 5) post-void residual urine volume (PVR) of less than 150 mL; and 6) age of 50 years or older.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
To compare patient background and objective findings from PFS performed at baseline and post-treatment between good and poor responders in symptom improvement.

Countries

Japan

Contacts

Public ContactYoshihisa Matsukawa

Nagoya University Graduate School of Medicine Department of Urology

yoshi44@med.nagoya-u.ac.jp+81-52-744-2985

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026