- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943735
This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder
November 7, 2018 updated by: Pfizer
A 13-Week, Single-Arm, Open-Label, Multicenter Study To Evaluate Refill Adherence And Satisfaction With Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder.
The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a non-interventional, observational study.
Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits
Study Type
Observational
Enrollment (Actual)
774
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
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
fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits
Description
Inclusion Criteria:
- Male or female outpatients >=18 years old
- Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.
Exclusion Criteria:
- Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)
- Have participated in any other studies involving study drugs within 30 days prior to entry in the study
- Subjects who have previously taken fesoterodine.
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 |
Intervention / Treatment |
---|---|
Fesoterodine arm
subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy
|
Fesoterodine 4 mg and 8 mg QD
early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment
Time Frame: Enrollment (Day 0) up to 90 days
|
Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90.
Rx fills could happen as early as Day 0, 30, and 60 of the study period.
Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill.
Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit.
Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.
|
Enrollment (Day 0) up to 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)
Time Frame: Enrollment (Day 0) up to 90 days
|
The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period.
Primary adherence was met if the participant filled at least 1 fesoterodine prescription during the study period.
|
Enrollment (Day 0) up to 90 days
|
Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period
Time Frame: Enrollment (Day 0) up to 90 days
|
The prototypical pattern was to fill 3 separate prescriptions, each for a 30-day supply, between the enrollment date and Day 90 of the study period; these prescription fills could happen as early as Day 0, 30, and 60 of the study period.
At enrollment, the Investigator provided participants with a prescription for fesoterodine 4mg or 8mg to be filled at a pharmacy of their choice.
The first refill indicated that 2 fesoterodine prescriptions had been filled.
|
Enrollment (Day 0) up to 90 days
|
Percentage of Participants Who Visited the YourWay Website
Time Frame: Baseline up to 90 days
|
YourWay plan was available and accessible to all participants prescribed fesoterodine, but was not defined as an explicit or required component.
Plan included motivational support for taking fesoterodine and behavioral interventions shown in clinical studies to improve participants' Overactive Bladder (OAB) outcomes.
Objectives included intervening quickly after treatment initiation, before participants had an opportunity to discontinue medication, reinforcing the treatable nature of OAB, and setting appropriate expectations for onset of action with therapy and degree of symptom improvement.
|
Baseline up to 90 days
|
Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit
Time Frame: Baseline up to 90 days
|
YourWay plan included a starter pack with a 14-day supply of 4 mg or 8 mg fesoterodine; guidebook for YourWay plan components and lifestyle modification tips; plan progress tracker with additional lifestyle tips; plan enrollment form.
About 1 week after plan enrollment, participants received a resource kit by mail which included: a cover letter; brochures for "Core 4" elements (food and drink, teach your bladder, daily fesoterodine, and track your progress); bladder diary and "track your progress" brochure; and recipes using bladder-friendly foods.
|
Baseline up to 90 days
|
Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms
Time Frame: Baseline up to 90 days
|
The use of the YourWay plan was optional but was available to all participants and included guidance for food and drink choices, bladder training, treatment compliance, and use of a daily tracker.
|
Baseline up to 90 days
|
Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices
Time Frame: Baseline up to 90 days
|
The use of the YourWay plan was optional but was available to all participants and included bladder-friendly food and drink choices and recipes as well as information for maintaining hydration and avoidance of potential bladder irritants (such as caffeine, citrus fruits and juices, artificial sweeteners, tomato-based foods, soda, alcohol, and spicy foods).
|
Baseline up to 90 days
|
Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"
Time Frame: Baseline up to 90 days
|
The use of the YourWay plan was optional but was available to all participants and included bladder training techniques such as to urinate each day when getting up and before going to bed, gradually increasing the amount of time between urinating, staying with timing goals whether there was a need to urinate or not, and bladder control tips (such as pelvic floor muscle squeeze, sit down and take 5 deep breaths, or stating "I'm the boss - not my bladder").
|
Baseline up to 90 days
|
Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker
Time Frame: Baseline up to 90 days
|
YourWay Daily Core 4 Tracker to track daily progress in the 4 core areas of food and drink (make more informed choices), teach your bladder (train your bladder to "wait"), daily Toviaz® (always take as directed), and keep track (share with your doctor).
|
Baseline up to 90 days
|
Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary
Time Frame: Baseline up to 90 days
|
For each week, the 12 Week Tracker included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).
|
Baseline up to 90 days
|
Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan
Time Frame: Baseline up to 90 days
|
Participants were recruited for study participation when they presented with OAB symptoms during regularly-scheduled physician visits; screening and enrollment occurred during the same visit.
Follow-up visits could be scheduled per standard clinical practice.
|
Baseline up to 90 days
|
Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice
Time Frame: Baseline up to 90 days
|
YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks.
The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.
|
Baseline up to 90 days
|
Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)
Time Frame: Baseline up to 90 days
|
Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.
|
Baseline up to 90 days
|
Percentage of Participants Who Agreed That They Learned Something About Their Condition
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors
Time Frame: Baseline up to 90 days
|
The use of the YourWay plan was optional but was available to all participants and included healthy bladder behaviors such as setting and maintaining personal goals and choice of bladder-friendly food and drinks.
|
Baseline up to 90 days
|
Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls
Time Frame: Baseline up to 90 days
|
YourWay participants received 6 telephone calls from an automated speech-recognition system over a period of approximately 11 weeks.
The calls included reinforcement of treatment participation, treatment expectations, compliance, general health messages regarding OAB, review of training materials, optional weekly email communication, and a wrap-up call which included a summary of lessons learned from each of the Core 4 lessons calls and guidance to find additional information about medication and lifestyle tips to support management of OAB symptoms.
|
Baseline up to 90 days
|
Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers
Time Frame: Baseline up to 90 days
|
Treatment goals and bladder symptoms progress trackers were incorporated in the 12 Week Tracker which included a participant determined weekly goal, a reminder to fill the prescription (if appropriate interval), participant reported progress in response to "this week I did well at", and a 7-day Daily Core 4 Tracker checklist (food and drink, teach your bladder, daily fesoterodine, and track your progress).
|
Baseline up to 90 days
|
Percentage of Participants Who Reported They Were Satisfied With Their Physician
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it
Time Frame: Baseline up to 90 days
|
Baseline up to 90 days
|
|
Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview
Time Frame: Enrollment (Day 0) up to 90 days
|
Enrollment (Day 0) up to 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
July 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
July 20, 2009
First Submitted That Met QC Criteria
July 21, 2009
First Posted (Estimate)
July 22, 2009
Study Record Updates
Last Update Posted (Actual)
December 4, 2018
Last Update Submitted That Met QC Criteria
November 7, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Fesoterodine
Other Study ID Numbers
- A0221078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overactive Bladder
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
-
Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
-
Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
-
Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
-
Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
-
Beijing Pins Medical Co., LtdUnknown
-
Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
-
Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey
Clinical Trials on Fesoterodine
-
PfizerCompletedUrinary Bladder, NeurogenicJapan
-
PfizerCompletedUrinary Bladder, NeurogenicFrance, United States, Spain, Korea, Republic of, United Kingdom, Malaysia, Taiwan, Finland, Japan, Lithuania, Italy, Turkey, Estonia, Slovakia, Belgium, Canada, Germany, Greece, India, Philippines, Poland, Russian Federation, South... and more
-
PfizerCompletedNeurogenic Detrusor OveractivityBelgium
-
PfizerCompletedOveractive BladderKorea, Republic of, United States, Denmark, Germany, Canada, Hungary, Poland, France, United Kingdom, Slovakia, Sweden, Mexico, Czech Republic, Finland, Italy, Lithuania, Argentina, Chile, Colombia, Egypt, Greece, Norway, Philippines, Russian Federation and more
-
PfizerCompletedOveractive BladderCosta Rica, United States, Korea, Republic of, Germany, Slovakia, Ukraine, Belgium, Poland, Czechia
-
PfizerTerminated
-
PfizerCompletedNeurogenic Detrusor OveractivityBelgium
-
PfizerCompletedUrinary Bladder, OveractivePortugal, Spain, Turkey, Finland, Germany, Norway, Sweden, Slovakia, Italy, Austria, United Kingdom, Belgium, Denmark, Israel, Switzerland