Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms

Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms - Comparative study of safety and efficacy due to the dose change from 4 mg to 8 mg silodosin for benign prostatic hyperplasia with lower urinary tract symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008483

Enrollment

200

Registered

2012-09-01

Start date

2012-09-01

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 Prostatic Hyperplasia

Interventions

Given the 4 mg once daily silodosin for 12 weeks in patients newly diagnosed with benign prostatic hyperplasia and, since then the 4 mg silodosin twice daily for 12 weeks Given the 4 mg once daily sil

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Men aged over 50 and under 80 years old 2) International Prostate Symptom Score (IPSS) of>7 3) a prostate volume of >20ml 4) a maximum urinary flow rate (Qmax) of <15ml/s 5) The patients are obtained the informed consent 6) The patients undergone Wash out period 4 weeks or more (switching patients from another alpha-1 blocker)

Exclusion criteria

Exclusion criteria: 1) patients are having the disease other than a benign prostatic hyperplasia (prostate cancer, bladder tumors, bladder stones, prostatitis, bladder neck sclerosis, patients, etc.) 2) Patients have received TUR-P, balloon dilation, urethral stent, hyperthermia, or radiation therapy to the pelvis, within 6 months of the start of the study 3) Self-catheterization 4) Patients with urinary tract infection 5) Patients with concomitant disease and other nervous system diseases, and it suspected to be neurogenic bladder 6) Patients with concomitant severe ischemic heart disease, cerebrovascular disease, liver dysfunction, renal dysfunction. 7) Patients with hypotension 8) Patients are having hypersensitivity to silodosin, naftopidil or taking vardenafil hydrochloride 9) Patients have treated with hormonal drug within 6 months 10) Patients treated with drugs other than tamsulosin is considered effective on urinary symptoms within a week 11) Patients was deemed by the physician as inappropriate to attend

Design outcomes

Primary

Measure	Time frame
IPSS Score, QOL Score, Blood pressure	—

Secondary

Measure	Time frame
maximum urinary flow rate (Qmax), residual urine volume	—

Countries

Japan

Contacts

Public ContactToshiro Shirakawa

Kobe University Graduate School of Medicine Division of Urology

toshiro@med.kobe-u.ac.jp078-382-6155

Outcome results

None listed

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