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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000011491 | Other Identifier | UMIN Clinical Trials Registry (UMIN-CTR) |
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| Name | Class |
|---|---|
| Shinshu University Hospital | UNKNOWN |
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This study is to evaluate the efficacy and safety that the occurrence of incontinence is significantly decrease using the propiverine hydrochloride for 200 female patients with mixed (stress and urge) urinary incontinence in one week during a twelve-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propiverine Hydrochloride Administration | Other | Administration of Propiverine Hydrochloride for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propiverine Hydrochloride | Drug | Administrate Propiverine Hydrochloride for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of incontinence | Change in occurrence of incontinence during a twelve-week treatment | during a twelve-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| The number of protective pad used | Change in the number of protective pad used during a twelve-week treatment period | during a twelve-week treatment period |
| Reduction ratio of the occurrence for incontinence |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum urethral closure pressure | Change in maximum urethral closure pressure during a twelve-week treatment period | during a twelve-week treatment period |
| Functional profile length | Change in functional profile length during a twelve-week treatment period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Nishizawa, M.D., Ph.D. | Shinshu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shinshu University Hospital | Matsumoto | Nagano | 390-8621 | Japan |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C015586 | propiverine |
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Change in reduction ratio of the occurrence for incontinence during a twelve-week treatment period
| during a twelve-week treatment period |
| ICIQ-Short Form(SF) scores | Change in ICIQ-SF scores during a twelve-week treatment period | during a twelve-week treatment period |
| I-QOL scores | Change in I-QOL scores during a twelve-week treatment period | during a twelve-week treatment period |
| IPSS-QOL scores | Change in IPSS-QOL scores during a twelve-week treatment period | during a twelve-week treatment period |
| IPSS symptom scores | Change in IPSS symptom scores during a twelve-week treatment period | during a twelve-week treatment period |
| OABSS symptom scores | Change in OABSS symptom scores during a twelve-week treatment period | during a twelve-week treatment period |
| Blood pressure | Change in blood pressure during a twelve-week treatment period | during a twelve-week treatment period |
| Pulse rate | Change in pulse rate during a twelve-week treatment period | during a twelve-week treatment period |
| Safety assessment | The occurrence of adverse events during a twelve-week treatment period | during a twelve-week treatment period |
| during a twelve-week treatment period |
| 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 |