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

January 29, 2013 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with overactive bladder symptoms presenting during routine clinical practice visits

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Toviaz(fesoterodine) plus educational materials
Other: Toviaz(fesoterodine) plus educational materials
Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.
Toviaz(fesoterodine) alone
Toviaz(fesoterodine) without additional educational materials
Other: Toviaz(fesoterodine) without educational materials
No educational materials

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Satisfied With Treatment at Month 4
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline, Week 4, 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
Time Frame: Baseline, Week 4, 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
Time Frame: Baseline, Week 4, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0221073
  • FACTS (FAKTEN) study

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