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
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Overactive Bladder Incontinence Adherence Behavioral interventions
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits

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

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.

Primary outcomes:
measure: Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment
timeFrame: Enrollment (Day 0) up to 90 days
Secondary outcomes:
measure: Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)
timeFrame: Enrollment (Day 0) up to 90 days
measure: Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period
timeFrame: Enrollment (Day 0) up to 90 days
measure: Percentage of Participants Who Visited the YourWay Website
timeFrame: Baseline up to 90 days
measure: Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Learned Something About Their Condition
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported They Were Satisfied With Their Physician
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)
timeFrame: Baseline up to 90 days
measure: Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it
timeFrame: Baseline up to 90 days
measure: 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
timeFrame: Enrollment (Day 0) up to 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: