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

Phase 3

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: propiverine; Drug: tolterodine PR

• Registration Number: NCT00646880
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study Completion: 2003-08
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Last Update Submitted: 2008-03-28
• Study First Posted: 2008-03-31
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propiverine/tolterodine group	propiverine	-
Tolerodine/propiverine group	tolterodine PR	-

Primary Outcome Measures

Name	Time	Method
Parameters of detrusor activity, occurring throughout the duration of comparable AUM	28 days

Secondary Outcome Measures

Name	Time	Method
Patient's perception of urgency	28 days
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
The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.	42 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Seoul, Korea, Republic of