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Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy

Pfizer logo

Pfizer

Status

Terminated

Conditions

Urinary Bladder, Overactive

Treatments

Other: Toviaz(fesoterodine) plus educational materials
Other: Toviaz(fesoterodine) without educational materials

Study type

Observational

Funder types

Industry

Identifiers

NCT01091519
FACTS (FAKTEN) study
A0221073

Details and patient eligibility

About

Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

Full description

Patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. The study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (GPs) in Germany, thus representing a wide range of practices and populations. Each urologist or GP may invite patients to participate who have already been diagnosed with overactive bladder and prescribed Toviaz according to their usual standard of care. Study enrollment stopped on December 31, 2011 due to difficulty in recruiting patients. No safety issues were related to the decision to stop patient enrollment.

Enrollment

781 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom Toviaz was prescribed for treatment of the symptoms.

Patients will complete the OABv8 questionnaire and will need to meet a minimum score in order to be eligible for the study.

Exclusion criteria

Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.

Trial design

781 participants in 2 patient groups

Toviaz(fesoterodine) plus educational materials
Treatment:
Other: Toviaz(fesoterodine) plus educational materials
Toviaz(fesoterodine) alone
Description:
Toviaz(fesoterodine) without additional educational materials
Treatment:
Other: Toviaz(fesoterodine) without educational materials

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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