A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia

A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia - A randomized controlled study to evaluate the efficacy of tamsulosin monotherapy and it combination with mirabegron on patients with overactive bladder induced by benign prostatic hyperplasia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007269

Enrollment

100

Registered

2012-02-12

Start date

2012-01-01

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

Men with overactive bladder induced by benign prostatic hyperplasia

Interventions

Harnal (0.2mg daily) for 8weeks Batanis (50mg daily) and Harnal (0.2mg daily) for 8weeks.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Age > or = 50 years-old 2. Patients with benign prostatic hyperplasiua who are treated by tamsulosin at least for 8 weeks 3. OABSS (Q3, urgency score) > or = 2, OABSS (total score) > or = 3

Exclusion criteria

Exclusion criteria: 1. Patients with the real child plan 2. Patients suspected malignant disease 3. Patients with urinary retention 4. Ppatients with severe bladder diverticulum 5. Patients with urethral stricture 6. Patients with previous intrapelvic radiation 7. Patients with urinary tract infection, urinary stone, interstitial cystitis 8. Patients with performing clean intermittent catheterization 9. Patients with severe hepatic disorders, severe renal dysfunction and severe cardiovascular diseases 10.Patients who are judged as unsuitable for the trial by doctors.

Design outcomes

Primary

Measure	Time frame
Change in total score of OABSS at 8 weeks	—

Secondary

Measure	Time frame
Changes in total score of IPSS, QOL index and Qmax at 8 weeks	—

Countries

Japan

Outcome results

None listed

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