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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • Parameters of detrusor activity, occurring throughout the duration of comparable AUM
    • Time Frame: 28 days

Secondary Measures

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

Participating in This Clinical Trial

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: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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