A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.

Official Title
-----------------
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: propiverine
* Drug: tolterodine PR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of urinary urgency Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart Symptoms of overactive bladder for greater than or equal to 6 months Exclusion Criteria: Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test An average volume voided of >200 ml per micturition as verified on the micturition chart before randomization Total daily urine volume of >3000 ml as verified on the micturition chart before randomization

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propiverine/tolterodine group<br> | Drug: propiverine<br>* Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.<br>|
| Active Comparator: Tolerodine/propiverine group<br> | Drug: tolterodine PR<br>* Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of detrusor activity, occurring throughout the duration of comparable AUM |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pads used per 24 hours |  | 28 days | 
| Urge Incontinence |  | 28 days | 
| Number of urgency episodes |  | 28 days | 
| Number of micturitions per 24 hours |  | 28 days | 
| Volume voided per micturition |  | 28 days | 
| Patient's perception of bladder condition |  | 28 days | 
| Patient's perception of treatment benefit |  | 28 days | 
| Patient's perception of urgency |  | 28 days | 
| The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period. |  | 42 days |