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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646880

Enrollment

Registered

2008-03-31

Start date

2003-03-31

Completion date

2003-08-31

Last updated

2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

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.

Interventions

DRUGpropiverine

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.

DRUGtolterodine 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Parameters of detrusor activity, occurring throughout the duration of comparable AUM	28 days

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026