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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

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.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Imidafenacin

Group Type EXPERIMENTAL

Imidafenacin

Intervention Type DRUG

Tablet, 12 weeks twice daily

Fesoterodine

Group Type ACTIVE_COMPARATOR

Fesoterodine

Intervention Type DRUG

Tablet, 12 weeks once daily

Interventions

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Imidafenacin

Tablet, 12 weeks twice daily

Intervention Type DRUG

Fesoterodine

Tablet, 12 weeks once daily

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No