A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat

A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat - A Randomized controlled study to evaluate the efficacy on male lower urinary tract symptoms with overactive bladder of alpha 1-adrenoceptor antagonist in monotherapy and combination therapy with Eviprostat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002782

Enrollment

120

Registered

2009-12-25

Start date

2009-04-01

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

Male lower urinary tract symptoms with overactive bladder

Interventions

Harnal(0.2mg daily) for 12weeks EviprostatDB (3 tablets daily) and Harnal(0.2mg daily)for 12weeks.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. 50 <or= age < 80 2.IPSS >or= 8, IPSS-QOL >or= 2 3. OABSS(Q3)>or= 2,OABSS(TOTAL) >or= 3

Exclusion criteria

Exclusion criteria: 1. Patients taking medications considered likely to affect micturition 2. PSA>10ng/ml, Patients who suspected prostate cancer 3. Patients who suspected neurogenic bladder 4. Patients with urethral stricture 5. Patients with chronic prostatitis or active urinary tract infenction 6. Patients with previous surgery for BPH 7.Patients with previous intrapelvic radiation 8. Complications considered likely to affect micturition(bladder neck constriction,bladder calculus,urinary calculus, cerebrovascular disease etc). 9. Patients with severe hepatic disorders,severe renal dysfunction and severe cardiovascular disease 10. Patients with performing intermittent catheter insertion themselves 11. Patients with orthostatic hypotension 12.Patients taking OTC medication and dietary supplement considered likely to affect micturition

Design outcomes

Primary

Measure	Time frame
To evaluate by using Questionnaires for urinary symptoms(IPSS and OABSS) at 4,8 and 12 weeks.	—

Countries

Japan

Contacts

Public ContactYasuhiro Sumino

Oita University Faculty of Medicine Department of Urology

Outcome results

None listed

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