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

NCT00943735 | Completed Results

• 1 other identifier: A0221078
• Study Type: observational
• Target: 774
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Overactive Bladder

Keywords

Overactive Bladder Incontinence Adherence Behavioral interventions

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (29)

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

  Enrollment (Day 0) up to 90 days

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

  Enrollment (Day 0) up to 90 days

• Percentage of Participants Who Visited the YourWay Website

  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

  Baseline up to 90 days

Study Arms (1)

Fesoterodine arm

subjects who present with OAB symptoms during medical office visits and who appear to be candidates for fesoterodine therapy

Drug: Fesoterodine; Behavioral: Your Way

Interventions

Fesoterodine DRUG

Fesoterodine 4 mg and 8 mg QD

Fesoterodine arm

Your Way BEHAVIORAL

early intervention after treatment initiation and before patients have an opportunity to discontinue medication; reinforcing the treatable nature of OAB

Fesoterodine arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 4, 2018
• Results First Posted: March 15, 2012

Record last verified: 2018-11