A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

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

Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

896

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
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35234
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36117
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85051
        • Pfizer Investigational Site
      • Sun Lakes, Arizona, United States, 85248
        • Pfizer Investigational Site
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pfizer Investigational Site
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72204
        • Pfizer Investigational Site
    • California
      • Buena Park, California, United States, 90620
        • Pfizer Investigational Site
      • Foothill Ranch, California, United States, 92610
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • West Covina, California, United States, 91790
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Pfizer Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Pfizer Investigational Site
    • Florida
      • Chipley, Florida, United States, 32428
        • Pfizer Investigational Site
      • Davie, Florida, United States, 33328
        • Pfizer Investigational Site
      • Hallandale Beach, Florida, United States, 33009
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33145
        • Pfizer Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Pfizer Investigational Site
      • Murdock, Florida, United States, 33948
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Pfizer Investigational Site
      • Saint Cloud, Florida, United States, 34769
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Barnesville, Georgia, United States, 30204
        • Pfizer Investigational Site
      • Blue Ridge, Georgia, United States, 30513
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30034
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Naperville, Illinois, United States, 60564
        • Pfizer Investigational Site
      • Orland Park, Illinois, United States, 60462
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Pfizer Investigational Site
      • Shawnee Mission, Kansas, United States, 66203
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67205
        • Pfizer Investigational Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Pfizer Investigational Site
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Pfizer Investigational Site
      • Oxon Hill, Maryland, United States, 20745
        • Pfizer Investigational Site
    • Michigan
      • Jackson, Michigan, United States
        • Pfizer Investigational Site
      • Portage, Michigan, United States, 49002
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89146
        • Pfizer Investigational Site
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • Pfizer Investigational Site
      • Mount Laurel, New Jersey, United States, 08054
        • Pfizer Investigational Site
    • New York
      • Binghamton, New York, United States, 13901
        • Pfizer Investigational Site
      • Endicott, New York, United States, 13760
        • Pfizer Investigational Site
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
      • Kingston, New York, United States, 12401
        • Pfizer Investigational Site
    • North Carolina
      • Beaufort, North Carolina, United States, 28516
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28262
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27703
        • Pfizer Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
    • Oregon
      • Central Point, Oregon, United States, 97502
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Pfizer Investigational Site
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
      • Connellsville, Pennsylvania, United States, 15425
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19148
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19103
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19147
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
      • Stoneboro, Pennsylvania, United States, 16153
        • Pfizer Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Pfizer Investigational Site
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Pfizer Investigational Site
      • Huntingdon, Tennessee, United States, 38344
        • Pfizer Investigational Site
      • Lexington, Tennessee, United States, 38351
        • Pfizer Investigational Site
      • Savannah, Tennessee, United States, 38372
        • Pfizer Investigational Site
      • Selmer, Tennessee, United States, 38375
        • Pfizer Investigational Site
      • Waynesboro, Tennessee, United States, 38485
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Colleyville, Texas, United States, 76034
        • Pfizer Investigational Site
      • Friendswood, Texas, United States, 77546
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75093
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75093-5841
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84084
        • Pfizer Investigational Site
      • West Valley City, Utah, United States, 84120
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99207
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53221
        • Pfizer Investigational Site
      • New Berlin, Wisconsin, United States, 53151
        • Pfizer Investigational Site
      • Oregon, Wisconsin, United States, 53575
        • Pfizer Investigational Site
      • Wauwatosa, Wisconsin, United States, 53226
        • 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:

  • self-reported symptoms of OAB for ≥ 3 months prior to screening
  • OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
  • urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
  • patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

  • any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
  • any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
  • stress incontinence, functional, or overflow incontinence as determined by the investigator
  • symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
  • clinically significant urinary tract obstruction
  • history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
  • clinically significant interstitial cystitis or significant bladder pain syndrome

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tolterodine ER group
Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
OAB Bother Rating Scale at baseline
Time Frame: baseline
baseline
Change from baseline to Week 4 and 12 in micturition bladder diary variables
Time Frame: 12 weeks
12 weeks
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
Time Frame: 12 weeks
12 weeks
Change from baseline to Week 4 and 12 in AUA Symptom Index
Time Frame: 12 weeks
12 weeks
Change from baseline to Week 4 and 12 in OAB questionnaire
Time Frame: 12 weeks
12 weeks
Clinical Global Impression-Improvement at Week 12
Time Frame: 12 weeks
12 weeks
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
Time Frame: 12 weeks
12 weeks
To asses the safety of tolterodine in patients with OAB
Time Frame: 12 weeks
12 weeks

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

March 1, 2004

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 27, 2008

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

  • A6121001

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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