Skip to content

Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).

Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study). - Comparison of Mirabegron and Imidafenacin for efficacy and safety in Japanese female patients with overactive bladder: A randomized controlled trial (COMFORT Study).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010321
Enrollment
200
Registered
2013-03-26
Start date
2013-03-21
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

Mirabegron 50 mg is orally administered once daily for 12 weeks. Imidafenacin 0.1 mg is orally administered twice daily for 12 weeks.

Sponsors

Department of Urology, Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)OAB patients (urgency score >= 2 and total score >= 3 in overactive bladder symptom score [OABSS]). 2)Twenty year-old or more patients 3)Postmenopausal women 4)Patients from whom we received written informed consent

Exclusion criteria

Exclusion criteria: 1)Premenopausal women 2)Demonstrable stress urinary incontinence 3)Post-void residual urine volume is more than 100mL, or presence of previous bladder outlet obstruction (BOO) 4)Patients with obvious inflammation, urinary tract infection, urolithiasis or malignant disease of the pelvic organs 5)Patients who have administered prohibited substances 6)Patients with previous pelvic radiation or surgery. 7)Patients who have received prohibited therapy 8)Patients who have contraindication of anticholinergic agents or Mirabegron 9)Patients with severe hepatic or renal dysfunction 10)Patients who have allergies for anticholinergic or beta-adrenergic agents 11)Patients who have received anticholinergic or beta-adrenergic agents within 12 months 12)Patients with severe cardiac dysfunction 13)Patients with arrhythmia 14)Patients with hypokalemia 15)Patients with polyuria 16)Any other patients whom the attending physician considered ineligible

Design outcomes

Primary

MeasureTime frame
Change of total overactive bladder symptom score (OABSS)

Countries

Japan

Contacts

Public ContactAtsushi Otsuka

Hamamatsu University School of Medicine Department of Urology

otsuka@hama-med.ac.jp053-435-2306

Outcome results

None listed

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