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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: propiverine
  • 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.
• Drug: tolterodine PR
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Propiverine/tolterodine group
• Active Comparator: Tolerodine/propiverine group

Primary Measures

• Parameters of detrusor activity, occurring throughout the duration of comparable AUM
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• Number of pads used per 24 hours
  • Time Frame: 28 days
    Safety Issue?: No
• Urge Incontinence
  • Time Frame: 28 days
    Safety Issue?: No
• Number of urgency episodes
  • Time Frame: 28 days
    Safety Issue?: No
• Number of micturitions per 24 hours
  • Time Frame: 28 days
    Safety Issue?: No
• Volume voided per micturition
  • Time Frame: 28 days
    Safety Issue?: No
• Patient's perception of bladder condition
  • Time Frame: 28 days
    Safety Issue?: No
• Patient's perception of treatment benefit
  • Time Frame: 28 days
    Safety Issue?: No
• Patient's perception of urgency
  • Time Frame: 28 days
    Safety Issue?: No
• The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.
  • Time Frame: 42 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646880

Study ID Number: DETAOD-0084-055

ClinicalTrials.gov Identifier: NCT00646880

Health Authority: Korea: Food and Drug Administration

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