Toviaz Post Marketing Surveillance Study

Study Overview
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Brief Summary
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The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Detailed Description
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continuous registration method

Official Title
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Toviaz treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors. Exclusion Criteria: Hypersensitivity to the active substance or to peanut or soya or any of the excipients Urinary retention Gastric retention Uncontrolled narrow angle glaucoma Myasthenia gravis Severe hepatic impairment (Child Pugh C) Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment Severe ulcerative colitis Toxic megacolon Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OAB-Toviaz<br>All patients who enrolled in this study | Drug: Toviaz treatment<br>* 4 mg starting then can be followed by 8 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs. | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug. | 
| Investigator's Final Assessment of Effectiveness at the End of Study Treatment | The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI). | At the end of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment | The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. | Baseline and at the end of study treatment | 
| Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment | The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. | Baseline and at the end of study treatment | 
| Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment | The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit. | Baseline and at the end of study treatment | 
| Participant Perception of Bladder Condition at the End of Study Treatment | Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems. | Baseline and at the end of study treatment | 
| Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics | Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as effective. Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) . | At the end of study treatment |