Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency) In Overactive Bladder Subjects Who Were Dissatisfied With Their Most Recent Antimuscarinic OAB Medication Therapy.

To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

417

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Pfizer Investigational Site
      • Sun Lakes, Arizona, United States
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States
        • Pfizer Investigational Site
      • Buena Park, California, United States
        • Pfizer Investigational Site
      • Mission Viejo, California, United States
        • Pfizer Investigational Site
      • Modesto, California, United States
        • Pfizer Investigational Site
      • Oceanside, California, United States
        • Pfizer Investigational Site
      • Paramount, California, United States
        • Pfizer Investigational Site
      • Sacramento, California, United States
        • Pfizer Investigational Site
      • Torrance, California, United States
        • Pfizer Investigational Site
      • Tustin, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Pfizer Investigational Site
      • Wheat Ridge, Colorado, United States
        • Pfizer Investigational Site
    • Florida
      • Hallandale Beach, Florida, United States
        • Pfizer Investigational Site
      • Orlando, Florida, United States
        • Pfizer Investigational Site
      • Wellington, Florida, United States
        • Pfizer Investigational Site
    • Georgia
      • Woodstock, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Libertyville, Illinois, United States
        • Pfizer Investigational Site
      • Mattoon, Illinois, United States
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Milford, Massachusetts, United States
        • Pfizer Investigational Site
    • Missouri
      • Manchester, Missouri, United States
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States
        • Pfizer Investigational Site
    • New Jersey
      • Westhampton, New Jersey, United States
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States
        • Pfizer Investigational Site
      • Bronx, New York, United States
        • Pfizer Investigational Site
      • Endwell, New York, United States
        • Pfizer Investigational Site
      • Garden City, New York, United States
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States
        • Pfizer Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States
        • Pfizer Investigational Site
    • Ohio
      • Canton, Ohio, United States
        • Pfizer Investigational Site
      • Zanesville, Ohio, United States
        • Pfizer Investigational Site
    • Oklahoma
      • Norman, Oklahoma, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Pfizer Investigational Site
      • Bala-Cynwyd, Pennsylvania, United States
        • Pfizer Investigational Site
      • Camp Hill, Pennsylvania, United States
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States
        • Pfizer Investigational Site
      • Williamsport, Pennsylvania, United States
        • Pfizer Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States
        • Pfizer Investigational Site
    • Tennessee
      • Bartlett, Tennessee, United States
        • Pfizer Investigational Site
      • Johnson City, Tennessee, United States
        • Pfizer Investigational Site
      • New Tazewell, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, United States
        • Pfizer Investigational Site
    • Washington
      • Mountlake Terrace, Washington, United States
        • Pfizer Investigational Site
      • Spokane, Washington, United States
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects greater than or equal to 18 years of age
  • Overactive bladder symptoms for at least 3 months
  • Previously treated with antimuscarinic OAB medications

Exclusion Criteria:

  • Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question

Secondary Outcome Measures

Outcome Measure
Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
Reasons for treatment withdrawal.
Adverse events during the 16 week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 29, 2005

First Submitted That Met QC Criteria

September 29, 2005

First Posted (Estimate)

October 3, 2005

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6121146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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