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

Study Overview
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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.

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.

Official Title
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Facts Study (Fakten-studie): Non-interventional Study to Investigate Whether Information Provided to Patients Influences Satisfaction With Toviaz Therapy As Perceived by the Patient

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Other: Toviaz(fesoterodine) plus educational materials
* Other: Toviaz(fesoterodine) without educational materials


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Toviaz(fesoterodine) plus educational materials<br> | Other: Toviaz(fesoterodine) plus educational materials<br>* Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.<br>|
| Toviaz(fesoterodine) alone<br>Toviaz(fesoterodine) without additional educational materials | Other: Toviaz(fesoterodine) without educational materials<br>* No educational materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Satisfied With Treatment at Month 4 | Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: overall, how satisfied are you with your OAB medication? and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including very satisfied and somewhat satisfied) and dissatisfied (including very dissatisfied, somewhat dissatisfied, and neither dissatisfied nor satisfied). | Month 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: Which of the following statements describes your bladder condition best at the moment? 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2). | Baseline, Week 4, Month 4 | 
| Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: Which of the following would typically describe your experience when you have a desire to urinate? 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change). | Baseline, Week 4, Month 4 | 
| Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: overall how satisfied are you with your over active bladder (OAB) medication? 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2). | Baseline, Week 4, Month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-interventional study fesoterodine educational materials