Urinary Bladder, OveractiveNCT01091519
Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy
An observational study of Urinary Bladder, Overactive, run by Pfizer.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Toviaz(fesoterodine) plus educational materials and Toviaz(fesoterodine) without educational materials
- How many people
- 781 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with overactive bladder symptoms presenting during routine clinical practice visits
Who may be able to join
- 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.
Who cannot join
- Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Toviaz(fesoterodine) plus educational materials, Toviaz(fesoterodine) without educational materials
- Keywords
- Non-interventional study fesoterodine educational materials
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toviaz(fesoterodine) plus educational materialsOther
Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.
Toviaz(fesoterodine) without educational materialsOther
No educational materials
| Study group | Role | What they receive |
|---|---|---|
| Toviaz(fesoterodine) plus educational materials | Not described Receives: Other: Toviaz(fesoterodine) plus educational materials | |
| Toviaz(fesoterodine) alone | Toviaz(fesoterodine) without additional educational materials Receives: Other: Toviaz(fesoterodine) without educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: Month 4
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: Baseline, Week 4, Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091519
- Sponsor's protocol ID
- A0221073
- Other IDs
- FACTS (FAKTEN) study
- Status last verified
- Jan 2013
- First submitted
- 17 Mar 2010
- Last updated
- 7 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schneider T, Arumi D, Crook TJ, Sun F, Michel MC. An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material. Int J Clin Pract. 2014 Sep;68(9):1074-80. doi: 10.1111/ijcp.12450. Epub 2014 May 5.
PubMed 24797765
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facts Study (Fakten-studie): Non-interventional Study to Investigate Whether Information Provided to Patients Influences Satisfaction With Toviaz Therapy As Perceived by the Patient
- ClinicalTrials.gov ID
- NCT01091519
- Acronym / sponsor ID
- A0221073
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Non-interventional study fesoterodine educational materials
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 781 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Posted 7 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toviaz(fesoterodine) plus educational materials | – | Other: Toviaz(fesoterodine) plus educational materials |
| Toviaz(fesoterodine) alone | – | Other: Toviaz(fesoterodine) without educational materialsToviaz(fesoterodine) without additional educational materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with overactive bladder symptoms presenting during routine clinical practice visits
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toviaz(fesoterodine) plus educational materialsEducational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue. | Other | Toviaz(fesoterodine) plus educational materials |
| Toviaz(fesoterodine) without educational materialsNo educational materials | Other | Toviaz(fesoterodine) alone |
Primary outcome
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").
3 secondary outcomes
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24797765Schneider T, Arumi D, Crook TJ, Sun F, Michel MC. An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material. Int J Clin Pract. 2014 Sep;68(9):1074-80. doi: 10.1111/ijcp.12450. Epub 2014 May 5.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Satisfied With Treatment at Month 4 (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2013.