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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: tolterodine PR; Drug: propiverine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646880

DETAOD-0084-055

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Propiverine/tolterodine group

Active Comparator group

Treatment:

Drug: propiverine

Tolerodine/propiverine group

Active Comparator group

Treatment:

Drug: tolterodine PR