The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.

The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia. - The clinical study for evaluating the early efficacy and safty of alpha-1-adrenoreceptor antagonists in patient with benign prostatic hyperplasia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005151

Enrollment

100

Registered

2011-03-01

Start date

2011-03-01

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 (BPH)

Interventions

Silodosin 4mg twice daily Tamsulosin hydrochloride 0.2mg daily

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: previously-untreated patients with BPH Total IPSS score>=8 and QOL score>=2

Exclusion criteria

Exclusion criteria: 1. residual volume>=50ml 2. cases with prostate cancer, bladder cancer or interstitial cystitis 3. cases with urethral stricture 4. cases with complications which may affect the lower urinary tract symptoms such as diabetes mellitus, cerebrovascular disease and spinal cord injury

Design outcomes

Primary

Measure	Time frame
International Prostatic Symptom Score (I-PSS) and QOL-Score	—

Secondary

Measure	Time frame
Uroflowmetry, Residual urine volume, Prostate volume ,Japanese-Gastrointestinal symptom Rating Scale,The Bristol Stool Form,Safety (adverse events),The rate of discontinuation	—

Countries

Japan

Contacts

Public ContactSeiji Matsumoto

Asahikawa Medical University Hospital Department of Renal and Urologic Surgery

0166-68-2533

Outcome results

None listed

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