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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00943735
First received: July 20, 2009
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The primary objective of the study is to assess the level of medication adherence observed among subjects receiving a specific combination of education and support materials (YourWay plan) along with a prescription for fesoterodine.


Condition Intervention
Overactive Bladder
Drug: Fesoterodine
Behavioral: Your Way

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 13-Week, Single-Arm, Open-Label, Multicenter Study To Evaluate Refill Adherence And Satisfaction With Fesoterodine Plus "Your Way" Patient Support Plan In Patients With Symptoms Of Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment [ Time Frame: Enrollment (Day 0) up to 90 days ] [ Designated as safety issue: No ]
    Prototypical pattern for meeting primary endpoint was to fill 3 separate prescriptions (Rx), each for a 30-day supply between enrollment and Day 90. Rx fills could happen as early as Day 0, 30, and 60 of the study period. Participants could also have chosen to wait until their 14-day medication sample was exhausted before receiving their first fill. Investigators received no prescribing restrictions, but were advised not to write Rx for a 90-day supply of fesoterodine at enrollment visit. Participants whose first observed Rx was for a ≥90-day supply were non-evaluable for the primary endpoint.


Secondary Outcome Measures:
  • Percentage of Participants Who Filled at Least One Fesoterodine Prescription During the Study Period (Primary Adherence) [ Time Frame: Enrollment (Day 0) up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Filled at Least Two Fesoterodine Prescriptions (First Refill) During the Study Period [ Time Frame: Enrollment (Day 0) up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Visited the YourWay Website [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Reported Having Adopted Lifestyle Changes to Help Improve Their Overactive Bladder (OAB) Symptoms [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Reported That They Trained Their Bladder to "Wait" [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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").

  • Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported That They Recorded Their Treatment Goals in the Daily Core 4 Tracker [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Reported That They Kept Track of Symptoms in the 12 Week Tracker Bladder Diary [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Reported That They Let Their Doctor Know How They Were Doing With the YourWay Plan [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That They Understood What to Expect From Their OAB Medication, Toviaz® (Fesoterodine) [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    Product indication and safety information was provided to all participants by the investigator and / or within the YourWay plan program information.

  • Percentage of Participants Who Agreed That They Learned Something About Their Condition [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That They Increased Their Knowledge of Healthy Bladder Behaviors [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported They Were Satisfied With the Participant Support Telephone Calls [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Who Reported They Were Satisfied With the Treatment Goals and Bladder Symptoms Progress Trackers [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Reported They Were Satisfied With Their Physician [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine) [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it [ Time Frame: Baseline up to 90 days ] [ Designated as safety issue: No ]
  • Comparison of Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it, Between Enrollment Date and End of Study CATI Interview [ Time Frame: Enrollment (Day 0) up to 90 days ] [ Designated as safety issue: No ]

Enrollment: 774
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fesoterodine arm
subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy
Drug: Fesoterodine
Fesoterodine 4 mg and 8 mg QD
Behavioral: Your Way
early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB

Detailed Description:

This is a non-interventional, observational study. Study investigators will recruit symptomatic, fesoterodine-naïve subjects when they present with OAB symptoms during regularly-scheduled physician visits fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

fesoterodine-naïve subjects with OAB symptoms present during regularly-scheduled physician visits

Criteria

Inclusion Criteria:

  • Male or female outpatients >=18 years old
  • Eligible for receiving Toviaz 4mg or 8mg QD treatment based on the approved US label.

Exclusion Criteria:

  • Female subjects who are pregnant, lactating, or who are intending to become pregnant within 28 days after the completion of the study (use of contraceptives is not required to participate in the study)
  • Have participated in any other studies involving study drugs within 30 days prior to entry in the study
  • Subjects who have previously taken fesoterodine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943735

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00943735     History of Changes
Other Study ID Numbers: A0221078
Study First Received: July 20, 2009
Results First Received: November 16, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Overactive Bladder Incontinence Adherence Behavioral interventions

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014