Overactive Bladder
Conditions
Keywords
Overactive bladder
Brief summary
To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.
Interventions
DRUGImidafenacin
Tablet, 12 weeks twice daily
DRUGFesoterodine
Tablet, 12 weeks once daily
Sponsors
Kyorin Pharmaceutical Co.,Ltd
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with overactive bladder aged 20 years or more * subject who had the continuos symptom for 3 months or more * subject prepare a symptom diary and was deemed eligible for the study by the investigator * 8 times or more of daily mean urination frequency * 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency
Exclusion criteria
* subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year * subjects with diseases prohibiting anti-cholinergics from administration * subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications * subjects who received lower urinary tract surgery within 6 months * subjects with a catheter placed or intermittent catheterization * subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period * subjects who are within 1 month after other clinical study was completed * subjects having 100mL or more of residual urine * subjects who had acute urinary retention history * subjects who have been administered Prohibited concomitant medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0) | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | up to 24 weeks |
| laboratory test | up to 12 weeks |
| vital signs | up to 12 weeks |
| residual urine | up to 12 weeks |
| Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0) | up to 12 weeks |
Countries
South Korea
Outcome results
None listed