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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propiverine/tolterodine group | Active Comparator |
| |
| Tolerodine/propiverine group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of detrusor activity, occurring throughout the duration of comparable AUM | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pads used per 24 hours | 28 days | |
| Urge Incontinence | 28 days | |
| Number of urgency episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Seoul | 110-744 | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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. |
|
| 28 days |
| Number of micturitions per 24 hours | 28 days |
| Volume voided per micturition | 28 days |
| Patient's perception of bladder condition | 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 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C015586 | propiverine |
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