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

LG Life Sciences

Status and phase

Completed

Phase 4

Conditions

Overactive Bladder

Treatments

Drug: Imidafenacin

Drug: Fesoterodine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01578304

LG-IFCL002

Details and patient eligibility

About

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.

Enrollment

207 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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