Skip to main content
OpenTrials
Completed

NCT Number: NCT00646880

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propiverine

Drug

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.

tolterodine PR

Drug

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.

Primary outcomes

  1. Parameters of detrusor activity, occurring throughout the duration of comparable AUM

    Time frame: 28 days

Secondary outcomes

  1. Number of pads used per 24 hours

    Time frame: 28 days

  2. Urge Incontinence

    Time frame: 28 days

  3. Number of urgency episodes

    Time frame: 28 days

  4. Number of micturitions per 24 hours

    Time frame: 28 days

  5. Volume voided per micturition

    Time frame: 28 days

  6. Patient's perception of bladder condition

    Time frame: 28 days

  7. Patient's perception of treatment benefit

    Time frame: 28 days

  8. Patient's perception of urgency

    Time frame: 28 days

  9. The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2003
First posted
Mar 31, 2008
Registry last updated
Mar 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.