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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

781 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Bladder, Overactive

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Toviaz(fesoterodine) plus educational materials

Intervention Type OTHER

Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.

Toviaz(fesoterodine) alone

Toviaz(fesoterodine) without additional educational materials

Toviaz(fesoterodine) without educational materials

Intervention Type OTHER

No educational materials

Interventions

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Toviaz(fesoterodine) plus educational materials

Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.

Intervention Type OTHER

Toviaz(fesoterodine) without educational materials

No educational materials

Intervention Type OTHER

Eligibility Criteria

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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.