N/A N=11,157

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT01488578 ↗

Enrolled (actual)

11,157

Serious AEs

0.1%

Results posted

Jun 2012

Primary outcome: Primary: Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs). — 984 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Tolterodine tartrate (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).	984	—
PRIMARY Number of Participants Which Was Evaluated as "Degree of Satisfaction".	5609; 1033; 963; 175	—
PRIMARY Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.	6536; 1244	—
PRIMARY Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.	344; 194; 166	—
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs	3483; 3053	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies	317; 6219	=0.032 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Gender	2745; 3791	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Complications	3960; 2576	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Age	2060; 4476	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy	319; 130	<0.001 sig
SECONDARY Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants	18; 11; 10; 10; 6; 5	—
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder	2426; 3709; 401	=0.006 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency	5529; 829	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)	370; 882; 1380; 3523	=0.015 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day	1670; 710; 254	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment	698; 5753	<0.001 sig

Summary

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01488578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.