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This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.
Overactive bladder (OAB) represents a constellation of symptoms that must include urinary urgency as an essential symptom for the diagnosis. It is usually accompanied by daytime frequency and nighttime frequency (urgency incontinence is not an essential symptom) and impairs the patient's activities of daily living and quality of life (QOL).
The objective of this survey is to confirm QOL improvement in patients treated with Vesicare (Generic Name: solifenacin succinate), with the use of OAB-q (Overactive bladder questionnaire), a questionnaire for assessment of OAB symptoms and QOL. The effect of improvement of OAB symptoms by solifenacin on QOL will also be confirmed. This survey will not include male OAB patients since many of them have benign prostatic hyperplasia as a coexisting disease and their QOL is supposed to be affected by α1-blocker treatment. To define patient's response to solifenacin in terms of QOL more clearly, this survey will include only female OAB patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vesicare group | Who receive vesicare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesicare | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in OAB-q (overactive bladder questionnaire) | Baseline and at 12 weeks (or last observation period) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in OABSS (overactive bladder symptom score) | Baseline and at 12 weeks (or last observation period) | |
| Changes in satisfaction score for urination | Baseline and at 12 weeks (or last observation period) |
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Inclusion Criteria:
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Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
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| 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 |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kantou | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| Tōhoku | Japan |
| 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 |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |