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.
Overview
- Phase
- Not Applicable
- Intervention
- Fesoterodine
- Conditions
- Overactive Bladder
- Sponsor
- Pfizer
- Enrollment
- 774
- Primary Endpoint
- Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Fesoterodine arm
subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy
Intervention: Fesoterodine
Fesoterodine arm
subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy
Intervention: Your Way
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of Participants Who Reported They Were Satisfied With Their Physician(Baseline up to 90 days)
- Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)(Enrollment (Day 0) up to 90 days)
- Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period(Enrollment (Day 0) up to 90 days)
- Percentage of Participants Who Visited the YourWay Website(Baseline up to 90 days)
- Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful(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(Baseline up to 90 days)
- Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary(Baseline up to 90 days)
- Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand(Baseline up to 90 days)
- Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information(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(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives(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(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Learned Something About Their Condition(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors(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(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(Baseline up to 90 days)
- Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan(Baseline up to 90 days)
- Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls(Baseline up to 90 days)
- Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers(Baseline up to 90 days)
- Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)(Baseline up to 90 days)
- Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it(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(Enrollment (Day 0) up to 90 days)