Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Condition(s) targeted: Overactive Bladder

Intervention: Tolterodine tartrate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).

Number of Participants Which Was Evaluated as "Degree of Satisfaction".

Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.

Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.

Secondary outcome:

Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs

Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies

Risk Factors for the Proportion of Responders of Tolterodine-Gender

Risk Factors for the Proportion of Responders of Tolterodine-Complications

Risk Factors for the Proportion of Responders of Tolterodine-Age

Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy

Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants

Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder

Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency

Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)

Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day

Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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

Starting date: December 2006
Last updated: May 11, 2012