N/A
Completed N=774
This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder
Source: ClinicalTrials.gov NCT00943735 ↗Enrolled (actual)
774
Serious AEs
1.7%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment — 10.4 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment |
10.4 | — |
| SECONDARY Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence) |
26.2 | — |
| SECONDARY Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period |
13.4 | — |
| SECONDARY Percentage of Participants Who Visited the YourWay Website |
28.8 | — |
| SECONDARY Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful |
3.0 | — |
| SECONDARY Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit |
97.3 | — |
| SECONDARY Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms |
85.3 | — |
| SECONDARY Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices |
82.4 | — |
| SECONDARY Percentage of Participants Who Reported That They Trained Their Bladder to "Wait" |
86.6 | — |
| SECONDARY Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed |
93.9 | — |
| SECONDARY Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker |
56.8 | — |
| SECONDARY Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary |
57.4 | — |
| SECONDARY Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan |
56.6 | — |
| SECONDARY Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand |
91.9 | — |
| SECONDARY Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information |
95.5 | — |
| SECONDARY Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice |
81.7 | — |
| SECONDARY Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives |
81.6 | — |
| SECONDARY Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition |
79.9 | — |
| SECONDARY Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine) |
88.2 | — |
| SECONDARY Percentage of Participants Who Agreed That They Learned Something About Their Condition |
87.0 | — |
| SECONDARY Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors |
85.3 | — |
| SECONDARY Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured |
93.8 | — |
| SECONDARY Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan |
72.4 | — |
| SECONDARY Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan |
86.9 | — |
| SECONDARY Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls |
78.5 | — |
| SECONDARY Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers |
74.1 | — |
| SECONDARY Percentage of Participants Who Reported They Were Satisfied With Their Physician |
93.4 | — |
| SECONDARY Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine) |
69.2 | — |
| SECONDARY Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it |
89.6 | — |
| SECONDARY 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 |
78.4; 89.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00943735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.