Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

Study Overview
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Brief Summary
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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.

Official Title
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Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Imidafenacin
* Drug: Fesoterodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imidafenacin<br> | Drug: Imidafenacin<br>* Tablet, 12 weeks twice daily<br>|
| Active Comparator: Fesoterodine<br> | Drug: Fesoterodine<br>* Tablet, 12 weeks once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 | 
| 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 | 
| Adverse events |  | up to 24 weeks | 
| laboratory test |  | up to 12 weeks | 
| vital signs |  | up to 12 weeks | 
| residual urine |  | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder