Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Study Overview
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Brief Summary
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The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Package Insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Detailed Description
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All the subjects whom an investigator prescribes the first Detrusitol Capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
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Postmarketing Observational Study of Tolterodine Treatment on Overactive Bladder in Real Life Setting

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Tolterodine tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects intend to treat their overactive bladder who are prescribed Detrusitol Capsule by their physicians. Exclusion Criteria: Subjects who have been prescribed Detrusitol Capsule before.
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 |
| --- | --- |
| Tolterodine tartrate.<br>Subjects taking Tolterodine tartrate. | Drug: Tolterodine tartrate<br>* Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.<br>* Other names: Detrusitol Capsule,Tolterodine tartrate.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. | 12 weeks | 
| Number of Participants Which Was Evaluated as Degree of Satisfaction. | Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above. | 12 week | 
| Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study. | Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period. | 12 week | 
| Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period. | The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher. | 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs | Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies | Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Gender | Number of participants with responders of tolterodine to determine whether male or female is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Complications | Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Age | Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor. | 12 week | 
| Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy | Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor. | 12 week | 
| Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants | All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder | Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency | Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep) | Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day | Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor. | 12 week | 
| Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment | Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor. | 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolterodine, Overactive Bladder, Japanese, Detrusitol, Detrol, Postmarketing commitment plan.