The efficacy of mirabegron additional therapy for elderly male lower urinary tract symptoms after treatment with a1-adrenergic receptor blocker

The efficacy of mirabegron additional therapy for lower urinary tract symptoms after treatment with a1-adrenergic receptor blocker monotherapy: prospective analysis of elderly men

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16759097

Enrollment

Registered

2016-07-08

Start date

2012-01-21

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Persistent male lower urinary tract symptoms (LUTS) and overactive bladder (OAB) symptoms Urological and Genital Diseases

Interventions

The patients continued all of their prescribed drugs during this study period. Before and 12 weeks after mirabegron (Betanis®, Astellas Pharma Inc., Tokyo, Japan

50 mg once daily) treatment was added to a previous a1-adrenergic receptor blocker for urinary symptoms, efficacy of the treatment was evaluated using the OABSS and International Prostate Symptom Sco

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male patients who had persistent lower urinary tract symptom and particularly overactive bladder symptoms, and had been taking a regular dose of a1-adrenergic receptor blockers for more than 12 weeks. 2. 65 years or older 3. total overactive bladder symptom score of 3 or more points with urinary urgency at least once per week

Exclusion criteria

Exclusion criteria: 1. Post void urine volume of 50 mL 2. History of urinary retention 3. Prior diagnosis of neurogenic bladder 4. Urethral stricture 5. Severe hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg) not well controlled by medication 6. Renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m2) 7. Liver impairment 8. Intention to have a child 9. Urological malignancy 10. Patients taking any anti-muscarinic drugs

Design outcomes

Primary

Measure	Time frame
1. The change of total overactive bladder symptom score 2. The change of total international prostate symptom score 3. Voided volume 4. Maximum flow rate 5. Post void residual urine volume Measured at between baseline and 12-weeks after treatment	—

Secondary

Measure	Time frame
1. The subscore of overactive bladder score 2. The subscore of intrenational prostate symptom score Measured at between baseline and 12-weeks after treatment	—

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026