Trial Outcomes & Findings for This Is An Open-Label Study To Evaluate Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder (NCT NCT00943735)

NCT ID: NCT00943735

Last Updated: 2018-12-04

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 774 participants
• Primary outcome timeframe: Enrollment (Day 0) up to 90 days
• Results posted on: 2018-12-04

Participant Flow

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.

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.

Participant milestones

Measure	Fesoterodine 4 mg or 8 mg Fesoterodine 4 mg or 8 mg tablet PO, QD
Overall Study STARTED	774
Overall Study Per Protocol Population	500
Overall Study COMPLETED	742
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Measure	Fesoterodine 4 mg or 8 mg Fesoterodine 4 mg or 8 mg tablet PO, QD
Overall Study Adverse Event	12
Overall Study Withdrawal by Subject	8
Overall Study Death	1
Overall Study Other	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fesoterodine 4 mg or 8 mg n=774 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Age, Customized 18 to 24 years	5 participants n=5 Participants
Age, Customized 25 to 44 years	119 participants n=5 Participants
Age, Customized 45 to 64 years	325 participants n=5 Participants
Age, Customized ≥ 65 years	325 participants n=5 Participants
Sex: Female, Male Female	593 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment (Day 0) up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=500 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
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 Interval 7.7 to 13.1

SECONDARY outcome

Timeframe: Enrollment (Day 0) up to 90 days

Population: PP population

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=500 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence)	26.2 percentage of participants Interval 22.5 to 29.9

SECONDARY outcome

Timeframe: Enrollment (Day 0) up to 90 days

Population: PP population

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=500 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period	13.4 percentage of participants Interval 10.5 to 16.3

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=337 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Visited the YourWay Website	28.8 percentage of participants Interval 24.0 to 33.9

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=337 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful	3.0 percentage of participants Interval 1.4 to 5.4

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=335 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit	97.3 percentage of participants Interval 95.0 to 98.8

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=339 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms	85.3 percentage of participants Interval 81.0 to 88.9

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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).

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=336 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices	82.4 percentage of participants Interval 77.9 to 86.4

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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").

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=335 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"	86.6 percentage of participants Interval 82.4 to 90.0

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=327 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed	93.9 percentage of participants Interval 90.7 to 96.2

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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).

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=340 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker	56.8 percentage of participants Interval 51.7 to 61.9

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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).

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=339 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary	57.4 percentage of participants Interval 52.4 to 62.4

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=332 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan	56.6 percentage of participants Interval 51.4 to 61.7

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=335 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand	91.9 percentage of participants Interval 88.5 to 94.6

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=334 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information	95.5 percentage of participants Interval 92.7 to 97.5

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=333 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
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 percentage of participants Interval 77.1 to 85.7

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=332 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives	81.6 percentage of participants Interval 77.0 to 85.6

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=336 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition	79.9 percentage of participants Interval 75.8 to 84.1

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=331 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine)	88.2 percentage of participants Interval 84.2 to 91.5

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=338 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Learned Something About Their Condition	87.0 percentage of participants Interval 82.9 to 90.4

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=339 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors	85.3 percentage of participants Interval 81.0 to 88.9

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=337 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured	93.8 percentage of participants Interval 90.6 to 96.1

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=330 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan	72.4 percentage of participants Interval 67.3 to 77.2

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=336 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan	86.9 percentage of participants Interval 83.3 to 90.4

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=325 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls	78.5 percentage of participants Interval 73.6 to 82.8

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

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).

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=328 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers	74.1 percentage of participants Interval 69.0 to 78.7

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=334 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported They Were Satisfied With Their Physician	93.4 percentage of participants Interval 90.2 to 95.8

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=328 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)	69.2 percentage of participants Interval 63.9 to 74.2

SECONDARY outcome

Timeframe: Baseline up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=335 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it	89.6 percentage of participants Interval 85.8 to 92.6

SECONDARY outcome

Timeframe: Enrollment (Day 0) up to 90 days

Population: 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.

Outcome measures

Measure	Fesoterodine 4 mg or 8 mg n=500 Participants Fesoterodine 4 mg or 8 mg tablet PO, QD
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 Good understanding at enrollment (n=500)	78.4 percentage of participants Interval 75.5 to 81.3
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 Good understanding at end of study (n=335)	89.6 percentage of participants Interval 85.8 to 92.6

Adverse Events

Fesoterodine 4 mg or 8 mg

Serious events: 13 serious events

Other events: 100 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fesoterodine 4 mg or 8 mg n=774 participants at risk Fesoterodine 4 mg or 8 mg tablet PO, QD
Cardiac disorders Arrhythmia	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Cardiac disorders Cardiac failure congestive	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Cardiac disorders Hypertensive heart disease	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Eye disorders Vision blurred	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
General disorders Chest pain	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Injury, poisoning and procedural complications Fall	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Cerebrovascular accident	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Syncope	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Psychiatric disorders Confusional state	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Urinary retention	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Skin and subcutaneous tissue disorders Pruritus	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Social circumstances Activities of daily living impaired	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Surgical and medical procedures Colporrhaphy	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Surgical and medical procedures Transurethral bladder resection	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Vascular disorders Hypertension	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.

Other adverse events

Measure	Fesoterodine 4 mg or 8 mg n=774 participants at risk Fesoterodine 4 mg or 8 mg tablet PO, QD
Eye disorders Cataract	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Eye disorders Dry eye	0.52% 4/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Eye disorders Vision blurred	1.4% 11/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Abdominal discomfort	0.39% 3/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Abdominal pain	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Constipation	3.2% 25/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Diarrhoea	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Dry mouth	2.8% 22/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.39% 3/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Nausea	0.52% 4/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Gastrointestinal disorders Oesophageal pain	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
General disorders Chills	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
General disorders Fatigue	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
General disorders Malaise	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Immune system disorders Hypersensitivity	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Infections and infestations Cystitis	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Infections and infestations Nasopharyngitis	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Infections and infestations Urinary tract infection	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Musculoskeletal and connective tissue disorders Muscle spasms	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Balance disorder	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Dizziness	0.52% 4/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Dysgeusia	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Headache	1.0% 8/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Nervous system disorders Somnolence	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Psychiatric disorders Anxiety	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Psychiatric disorders Insomnia	0.39% 3/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Psychiatric disorders Mood swings	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Psychiatric disorders Nightmare	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Bladder obstruction	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Cystitis interstitial	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Dysuria	0.65% 5/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Micturition urgency	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Pollakiuria	0.78% 6/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Urge incontinence	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Urinary incontinence	0.26% 2/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Renal and urinary disorders Urinary retention	1.0% 8/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Respiratory, thoracic and mediastinal disorders Dry throat	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Skin and subcutaneous tissue disorders Rash	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.
Vascular disorders Hot flush	0.13% 1/774 • Enrollment (Day 0) up to 28 days after last dose of study treatment 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.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER