Overactive bladder Overactive bladder
Conditions
Interventions
Assigned randomly to vibegron and imidafenacin combination group or vibegron monotherapy group
Sponsors
Kawahara Kazuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provided written informed consent 2) Aged 40 years or older 3) Outpatient 4) Treated with vibegron 50 mg daily for 4 weeks or more at eligibility assessment 5) Has OABSS total score >=3 and OABSS-Q3 (urinary urgency) >=2 at eligibility assessment
Exclusion criteria
Exclusion criteria: 1)Taking mirabegron 2)Has a contraindication to vibegron 3)Has a contraindication to anticholinergic 4)difficulty with urination 5)History of urinary retention 6)Arrhythmia 7)Hypokalemia 8)Serious liver dysfunction, Serious renal dysfunction 9)Post-void residual>=100ml at eligibility assessment 10)Has any of following; bladder cancer, prostate cancer, bladder stone, urethral calculus, cystitis interstitial, prostatitis, or urinary tract infection 11)True stress urinary incontinence 12)Suspicion of polyuria 13)Serious hypertension 14)Treated with any of medications prohibited or restricted in this study within 4 weeks before eligibility assessment 15)Underwent urologic or genital surgery within 6 months before eligibility assessment 16)Lower urinary symptom is unstable 17)The shift work, circadian rhythm disorder, and irregular lifestyle 18)Considered inappropriate for participating in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of OABSS score | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Regarding OABSS total score at each time point (2) Intergroup comparisons will be performed on the change from Week 0 in the following items at the final assessment. A paired statistical test will be performed between groups at each time point. 1) OABSS (Scores for 1. Daytime frequency, 2. Nighttime frequency, 3. Urgency, 4. Urgency incontinence) 2) Urination journal (Scores for mean number of voidings daily, mean number of nighttime voidings, mean urgency episodes daily, mean urgency incontinence episodes daily, mean urine volume per voiding, mean urine volume per nighttime voiding) 3) IPSS-QOL score 4) Residual urine volume (3) Multivariate analysis will be performed to study factors affecting the primary outcome (E.g., constructing a model that includes the presence and absence of imidafenacin). (4) An intergroup comparison of the PGI score will be performed. | — |
Contacts
Public ContactKazuya Kawahara
KAWAHARA Urology Clinic
Outcome results
None listed