Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan) (POTTOR)

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Tolterodine tartrate

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 11157

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects whom an investigator involving A6121186 prescribes the Tolterodine tartrate (Detrusitol Capsule).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tolterodine tartrate.; Subjects taking Tolterodine tartrate.	Drug: Tolterodine tartrate; Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.; Other Names: Detrusitol Capsule,Tolterodine tartrate.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Japanese; Overactive Bladder; Tolterodine; Detrusitol; Detrol; Postmarketing commitment plan.
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate
• Other Study ID Numbers: A6121186