This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00943735
• Collaborator: (none)
• Enrollment: 774
• Duration (Months): 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Fesoterodine; Behavioral: Your Way

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 Design

• Study Type: Observational
• Actual Enrollment: 774 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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 Start Date: Jul 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Fesoterodine arm subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy	Drug: Fesoterodine; Fesoterodine 4 mg and 8 mg QD; Behavioral: Your Way; early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment [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 Outcome Measures

1. Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence) [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.

2. Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period [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.

3. Percentage of Participants Who Visited the YourWay Website [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.

4. Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful [Baseline up to 90 days]

5. 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]

   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.

6. Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms [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.

7. Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices [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).

8. Percentage of Participants Who Reported That They Trained Their Bladder to "Wait" [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").

9. Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed [Baseline up to 90 days]

10. Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker [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).

11. Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary [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).

12. Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan [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.

13. Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand [Baseline up to 90 days]

14. Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information [Baseline up to 90 days]

15. 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]

    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.

16. Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives [Baseline up to 90 days]

17. 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]

18. Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine) [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.

19. Percentage of Participants Who Agreed That They Learned Something About Their Condition [Baseline up to 90 days]

20. Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors [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.

21. 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]

22. 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]

23. Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan [Baseline up to 90 days]

24. Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls [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.

25. Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers [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).

26. Percentage of Participants Who Reported They Were Satisfied With Their Physician [Baseline up to 90 days]

27. Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine) [Baseline up to 90 days]

28. Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it [Baseline up to 90 days]

29. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00943735
• Other Study ID Numbers: A0221078
• First Posted: Jul 22, 2009
• Last Update Posted: Dec 4, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Pfizer: Overactive Bladder Incontinence Adherence Behavioral interventions
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Fesoterodine

Study Results

Participant Flow

Recruitment Details	This was a non-interventional, observational study. Study investigators contacted through prescription records in the IMS Longitudinal prescription (LRx) Database recruited symptomatic, fesoterodine-naive subjects (N=788 recruited; 774 entered) when they presented with overactive bladder (OAB) symptoms during regularly-scheduled physician visits.
Pre-assignment Detail	The use and dosage recommendations for fesoterodine 4 milligram (mg) or 8 mg tablet taken by mouth (PO) once daily (QD) adhered completely to the approved product label and was adjusted solely according to medical and therapeutic necessity.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Period Title: Overall Study
STARTED	774
Per Protocol Population	500
COMPLETED	742
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Overall Participants	774
Age, Customized (participants) [Number]
18 to 24 years	5 0.6%
25 to 44 years	119 15.4%
45 to 64 years	325 42%
≥ 65 years	325 42%
Sex: Female, Male (Count of Participants)
Female	593 76.6%
Male	181 23.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment
Description	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.
Time Frame	Enrollment (Day 0) up to 90 days

Outcome Measure Data

Analysis Population Description

Per Protocol (PP) population: all participants who returned a signed informed consent form (Intent to Treat) and enrollment questionnaire, had evidence of ≥1 prescription in LRx database for any medication class, and did not receive an initial fesoterodine prescription for ≥ a 90-day supply.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	500
Number (95% Confidence Interval) [percentage of participants]	10.4 1.3%

2. Secondary Outcome

Title	Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)
Description	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.
Time Frame	Enrollment (Day 0) up to 90 days

Outcome Measure Data

Analysis Population Description

PP population

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	500
Number (95% Confidence Interval) [percentage of participants]	26.2 3.4%

3. Secondary Outcome

Title	Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period
Description	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.
Time Frame	Enrollment (Day 0) up to 90 days

Outcome Measure Data

Analysis Population Description

PP population

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	500
Number (95% Confidence Interval) [percentage of participants]	13.4 1.7%

4. Secondary Outcome

Title	Percentage of Participants Who Visited the YourWay Website
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	337
Number (95% Confidence Interval) [percentage of participants]	28.8 3.7%

5. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	337
Number (95% Confidence Interval) [percentage of participants]	3.0 0.4%

6. Secondary Outcome

Title	Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	335
Number (95% Confidence Interval) [percentage of participants]	97.3 12.6%

7. Secondary Outcome

Title	Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	339
Number (95% Confidence Interval) [percentage of participants]	85.3 11%

8. Secondary Outcome

Title	Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices
Description	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).
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	336
Number (95% Confidence Interval) [percentage of participants]	82.4 10.6%

9. Secondary Outcome

Title	Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"
Description	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").
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	335
Number (95% Confidence Interval) [percentage of participants]	86.6 11.2%

10. Secondary Outcome

Title	Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	327
Number (95% Confidence Interval) [percentage of participants]	93.9 12.1%

11. Secondary Outcome

Title	Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker
Description	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).
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	340
Number (95% Confidence Interval) [percentage of participants]	56.8 7.3%

12. Secondary Outcome

Title	Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary
Description	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).
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	339
Number (95% Confidence Interval) [percentage of participants]	57.4 7.4%

13. Secondary Outcome

Title	Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	332
Number (95% Confidence Interval) [percentage of participants]	56.6 7.3%

14. Secondary Outcome

Title	Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	335
Number (95% Confidence Interval) [percentage of participants]	91.9 11.9%

15. Secondary Outcome

Title	Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	334
Number (95% Confidence Interval) [percentage of participants]	95.5 12.3%

16. Secondary Outcome

Title	Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	333
Number (95% Confidence Interval) [percentage of participants]	81.7 10.6%

17. Secondary Outcome

Title	Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	332
Number (95% Confidence Interval) [percentage of participants]	81.6 10.5%

18. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	336
Number (95% Confidence Interval) [percentage of participants]	79.9 10.3%

19. Secondary Outcome

Title	Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)
Description	Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	331
Number (95% Confidence Interval) [percentage of participants]	88.2 11.4%

20. Secondary Outcome

Title	Percentage of Participants Who Agreed That They Learned Something About Their Condition
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	338
Number (95% Confidence Interval) [percentage of participants]	87.0 11.2%

21. Secondary Outcome

Title	Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	339
Number (95% Confidence Interval) [percentage of participants]	85.3 11%

22. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	337
Number (95% Confidence Interval) [percentage of participants]	93.8 12.1%

23. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	330
Number (95% Confidence Interval) [percentage of participants]	72.4 9.4%

24. Secondary Outcome

Title	Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	336
Number (95% Confidence Interval) [percentage of participants]	86.9 11.2%

25. Secondary Outcome

Title	Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls
Description	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.
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	325
Number (95% Confidence Interval) [percentage of participants]	78.5 10.1%

26. Secondary Outcome

Title	Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers
Description	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).
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	328
Number (95% Confidence Interval) [percentage of participants]	74.1 9.6%

27. Secondary Outcome

Title	Percentage of Participants Who Reported They Were Satisfied With Their Physician
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	334
Number (95% Confidence Interval) [percentage of participants]	93.4 12.1%

28. Secondary Outcome

Title	Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)
Time Frame	Baseline up to 90 days

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	328
Number (95% Confidence Interval) [percentage of participants]	69.2 8.9%

29. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; N=CATI response valid N: Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid N, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	335
Number (95% Confidence Interval) [percentage of participants]	89.6 11.6%

30. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

PP population; (n)=CATI response valid n at observation. Participants' interview responses were reported via a computer-assisted telephone interview (CATI) with a live interviewer on or around Day 86 of the study period. Participants may have omitted responses to individual items; valid n, therefore, may have varied from response to response.

Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
Measure Participants	500
Good understanding at enrollment (n=500)	78.4 10.1%
Good understanding at end of study (n=335)	89.6 11.6%

Adverse Events

Time Frame	Enrollment (Day 0) up to 28 days after last dose of study treatment
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Fesoterodine 4 mg or 8 mg
Arm/Group Description	Fesoterodine 4 mg or 8 mg tablet PO, QD
All Cause Mortality
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	13/774 (1.7%)
Cardiac disorders
Arrhythmia	1/774 (0.1%)
Cardiac failure congestive	1/774 (0.1%)
Hypertensive heart disease	1/774 (0.1%)
Eye disorders
Vision blurred	1/774 (0.1%)
General disorders
Chest pain	1/774 (0.1%)
Injury, poisoning and procedural complications
Fall	1/774 (0.1%)
Nervous system disorders
Cerebrovascular accident	1/774 (0.1%)
Syncope	1/774 (0.1%)
Psychiatric disorders
Confusional state	1/774 (0.1%)
Renal and urinary disorders
Urinary retention	1/774 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/774 (0.1%)
Chronic obstructive pulmonary disease	1/774 (0.1%)
Skin and subcutaneous tissue disorders
Pruritus	1/774 (0.1%)
Social circumstances
Activities of daily living impaired	1/774 (0.1%)
Surgical and medical procedures
Colporrhaphy	1/774 (0.1%)
Transurethral bladder resection	1/774 (0.1%)
Vascular disorders
Hypertension	1/774 (0.1%)
Other (Not Including Serious) Adverse Events
	Fesoterodine 4 mg or 8 mg
	Affected / at Risk (%)	# Events
Total	100/774 (12.9%)
Eye disorders
Cataract	1/774 (0.1%)
Dry eye	4/774 (0.5%)
Vision blurred	11/774 (1.4%)
Gastrointestinal disorders
Abdominal discomfort	3/774 (0.4%)
Abdominal pain	1/774 (0.1%)
Constipation	25/774 (3.2%)
Diarrhoea	2/774 (0.3%)
Dry mouth	22/774 (2.8%)
Gastrooesophageal reflux disease	3/774 (0.4%)
Nausea	4/774 (0.5%)
Oesophageal pain	1/774 (0.1%)
General disorders
Chills	1/774 (0.1%)
Fatigue	1/774 (0.1%)
Malaise	1/774 (0.1%)
Immune system disorders
Hypersensitivity	1/774 (0.1%)
Infections and infestations
Cystitis	1/774 (0.1%)
Nasopharyngitis	1/774 (0.1%)
Urinary tract infection	2/774 (0.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/774 (0.3%)
Muscle spasms	1/774 (0.1%)
Nervous system disorders
Balance disorder	1/774 (0.1%)
Dizziness	4/774 (0.5%)
Dysgeusia	1/774 (0.1%)
Headache	8/774 (1%)
Somnolence	1/774 (0.1%)
Psychiatric disorders
Anxiety	1/774 (0.1%)
Insomnia	3/774 (0.4%)
Mood swings	1/774 (0.1%)
Nightmare	2/774 (0.3%)
Renal and urinary disorders
Bladder obstruction	1/774 (0.1%)
Cystitis interstitial	1/774 (0.1%)
Dysuria	5/774 (0.6%)
Micturition urgency	2/774 (0.3%)
Pollakiuria	6/774 (0.8%)
Urge incontinence	1/774 (0.1%)
Urinary incontinence	2/774 (0.3%)
Urinary retention	8/774 (1%)
Respiratory, thoracic and mediastinal disorders
Dry throat	1/774 (0.1%)
Nasal congestion	1/774 (0.1%)
Respiratory disorder	1/774 (0.1%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/774 (0.1%)
Rash	1/774 (0.1%)
Rash maculo-papular	1/774 (0.1%)
Vascular disorders
Hot flush	1/774 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.