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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: Fesoterodine (Drug); Your Way (Behavioral)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Percentage of Participants Who Filled at Least 90 Days Supply of Fesoterodine (4mg QD or 8mg QD) Within 90 Days of Study Enrollment

Secondary outcome:

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

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

Percentage of Participants Who Visited the YourWay Website

Among Participants Who Used the YourWay Website, the Percentage of Participants Who Agreed That the Website Was Useful

Percentage of Participants Who Reported Having Read the YourWay Plan Materials Received From Their Physician or From the Resource Kit

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

Percentage of Participants Who Reported That They Made Bladder-friendly Food and Drink Choices

Percentage of Participants Who Reported That They Trained Their Bladder to "Wait"

Percentage of Participants Who Reported That They Took Toviaz® (Fesoterodine) as Directed

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

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

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

Percentage of Participants Who Agreed That They Found the YourWay Program Materials Easy to Understand

Percentage of Participants Who Agreed That the YourWay Program Provided a Good Amount of Information

Percentage of Participants Who Agreed That the YourWay Plan Provided a Strong Support System That Participants Could Count on for Information and Advice

Percentage of Participants Who Agreed That They Were Able to Incorporate the YourWay Plan Into Their Lives

Percentage of Participants Who Agreed That the YourWay Plan Helped Them Play a More Active Role in Managing Their Condition

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

Percentage of Participants Who Agreed That They Learned Something About Their Condition

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

Percentage of Participants Who Agreed That They Understand OAB is a Chronic Condition That Can be Successfully Managed, But Generally Not Cured

Percentage of Participants Who Reported They Felt Confident That They Could Manage Their OAB as a Result of the YourWay Plan

Percentage of Participants Who Reported They Were Satisfied With the Overall Content of the YourWay Plan

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

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

Percentage of Participants Who Reported They Were Satisfied With Their Physician

Percentage of Participants Who Reported the YourWay Plan Encouraged Their Use of Toviaz® (Fesoterodine)

Percentage of Participants Who Agreed That They Had a Good Understanding About Their Condition and How to Treat it

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

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

Starting date: July 2009
Last updated: February 10, 2012

Page last updated: August 23, 2015

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