Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

Launched by BUDDHIST TZU CHI GENERAL HOSPITAL · Feb 16, 2017

Keywords

ClinConnect Summary

Introduction

Overactive bladder syndrome (OAB) is defined as the symptom syndrome with frequency, and urgency with or without urgency incontinence. OAB affects more than 400 million people worldwide and has been estimated to affect around 16% of the adult population across Europe and the USA. In Asian countries, the prevalence of OAB has been reported to be 6% of men and women aged ≥18 years in China; 12.2% of men and women in Korea;12.4% of men and women aged ≥40 years in Japan; and 21 to 25% of women and 16.9% of community dwelling adults in Taiwan. Another study reported that the preval...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Symptoms of OAB for at least 12 weeks before initiation of the run-in period;
• • 2. An average of ≥8 micturitions per 24 hours,
• • 3. An average of ≥1 episode of urgency or urgency incontinence per 24-hours, during a 3-day micturition diary period.
• Exclusion Criteria:
• • 1. Stress urinary incontinence as a predominant symptom at screening;
• • 2. Urinary tract infection, urinary stone, interstitial cystitis or a history of recurrent urinary tract infection;
• • 3. Confirmed post-void residual (PVR) volume of ≥100 mL or more or with a clinically significant lower urinary tract obstructive disease;
• • 4. Proven neurogenic bladder such as stroke, Parkinson's disease, spinal cord injury, multiple sclerosis;
• • 5. Overt bladder outlet obstruction not adequately controlled.
• • 6. Severe medical disease that prohibit patients to undergo clinical investigation.
• • 7. Patient is currently taking medications that might affect lower urinary tract function, such as α1-adrenoreceptor antagonists; medication for diabetes insipidus, antidepressants, 5α reductase inhibitors, capsaicin, resiniferatoxin, or botulinum toxin into the bladder, were also restricted.