Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial

Good combination therapy with alpha-blocker plus imidafenacin or mirabegron for nocturia in overactive bladder with benign prostatic hyperplasia; prospective randomized trial - Good-Night study 2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010327

Enrollment

300

Registered

2013-03-27

Start date

2013-01-01

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

Overactive Bladder

Interventions

Any alpha-blocker plus imidafenacin 0.2mg/day bid. Any alpha-blocker plus mirabegron 50mg/day qd after meal

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Patients with 1) alpha-blocker treatment over 4 weeks 2) urinary urgency more than once a week (Question 3 of OABSS >=2) 3) nocturia more than twice a day on average in bladder diary 4) more than 20 years old

Exclusion criteria

Exclusion criteria: 1) Urinary retention within a year 2) Residual urine >=50mL 3) Strong suspect of prostate cancer 4) Treatment of any anti-muscarinic agent or beta-stimulants within a month. 5) Indwelling catheter or self intermittent urinary catherization 6) Diseases that affect nocturia (sleep apnea syndrome, restless legs syndrome, insomnia etc.) 7) The shift work, circadian rhythm disorder, and irregular lifestyle 8) Bladder training conducted over the past 10 days 9) Active acute urinary tract infection 10) Hormones or 5 alpha-reductase inhibitor started to have within the past six months 11) Contraindication to imidafenacin (primary angle-closure glaucoma, urinary retention, obstructive intestinal disease, paralytic ileus, gastrointestinal atony, myastania gravis) 12) Contraindication to mirabegron (severe heart disease, severe liver dysfunction, treatment of flecainide or propaphenone) 13) Untreated severe hypertension (more than Class II in JSH 2009, SBP>=160mmHg or DBP>= 100mmHg) 14) Judged as being unsuitable for the trial by physician.

Design outcomes

Primary

Measure	Time frame
Mean frequency of nocturnal mictrition	—

Secondary

Measure	Time frame
1) N-QOL 2) OABSS 3) IPSS&QOL 4) mean night-time urine volume 5) voided volume 6) residual urine volume 7) adverse events and side-effects	—

Countries

Japan

Contacts

Public ContactYasushi Miyagawa

Osaka-Hokuriku male LUTS Conference Secretariat(Osaka University Hospital) Urology

miyagawa@uro.med.osaka-u.ac.jp06-6879-3531

Outcome results

None listed

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