Special Investigation For Long Term Use Of Tolterodine (Regulatory 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 LPD (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 patients 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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Special Investigation For Long Term Use Of Detrusitol (Regulatory Post Marketing Commitment Plan).

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: Tolterodine tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients need to be administered Detrusitol® Capsule in order to be enrolled in the surveillance. Exclusion Criteria: Patients not administered Detrusitol® Capsule.
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>Patients 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.  The usual adult dosage for oral administration is 4 mg of tolterodine tartrate once daily. Occasionally dose reduction might be needed due to individual tolerability.<br>* Other names: Detrusitol® Capsule.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reaction Not Expected From the Japanese Package Insert. Number of Unlisted 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. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. | 52 weeks | 
| 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. | 52 weeks |