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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine arm | subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | Fesoterodine 4 mg and 8 mg QD |
| |
| Your Way |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment | 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. | Enrollment (Day 0) up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine 4 mg or 8 mg | Fesoterodine 4 mg or 8 mg tablet PO, QD |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fesoterodine 4 mg or 8 mg | Fesoterodine 4 mg or 8 mg tablet PO, QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment (Day 0) up to 90 days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine 4 mg or 8 mg | Fesoterodine 4 mg or 8 mg tablet PO, QD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Behavioral |
early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB |
|
| Enrollment (Day 0) up to 90 days |
| Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period | 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. | Enrollment (Day 0) up to 90 days |
| Percentage of Participants Who Visited the YourWay Website | 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. | Baseline up to 90 days |
| Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful | Baseline up to 90 days |
| Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit | 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. | Baseline up to 90 days |
| Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms | 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. | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices | 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). | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Trained Their Bladder to "Wait" | 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"). | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker | 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). | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary | 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). | Baseline up to 90 days |
| Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan | 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. | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand | Baseline up to 90 days |
| Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information | Baseline up to 90 days |
| Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice | 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. | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives | Baseline up to 90 days |
| Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine) | Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information. | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Learned Something About Their Condition | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors | 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. | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured | Baseline up to 90 days |
| Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan | Baseline up to 90 days |
| Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan | Baseline up to 90 days |
| Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls | 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. | Baseline up to 90 days |
| Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers | 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). | Baseline up to 90 days |
| Percentage of Participants Who Reported They Were Satisfied With Their Physician | Baseline up to 90 days |
| Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine) | Baseline up to 90 days |
| Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it | Baseline up to 90 days |
| Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview | Enrollment (Day 0) up to 90 days |
| Other |
|
| Other |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Fesoterodine 4 mg or 8 mg | Fesoterodine 4 mg or 8 mg tablet PO, QD |
|
|
| Secondary | Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence) | 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. | PP population | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment (Day 0) up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period | 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. | PP population | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment (Day 0) up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Visited the YourWay Website | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Trained Their Bladder to "Wait" | 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"). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine) | Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Learned Something About Their Condition | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers | 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported They Were Satisfied With Their Physician | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine) | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline up to 90 days |
|
|
|
| Secondary | Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Enrollment (Day 0) up to 90 days |
|
|
|
| 13 |
| 774 |
| 100 |
| 774 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Activities of daily living impaired | Social circumstances | MedDRA 14.0 | Non-systematic Assessment |
|
| Colporrhaphy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| Transurethral bladder resection | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Bladder obstruction | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Cystitis interstitial | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |