Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

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

A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder

The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

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
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Berkeley, California, United States, 94705
        • Pfizer Investigational Site
      • Oakland, California, United States, 94612
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94102
        • Pfizer Investigational Site
      • Santa Rosa, California, United States, 95405
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80202
        • Pfizer Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Pfizer Investigational Site
      • West Hartford, Connecticut, United States, 06117
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33759
        • Pfizer Investigational Site
      • Leesburg, Florida, United States, 34748
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33145
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409-1972
        • Pfizer Investigational Site
      • Weston, Florida, United States, 33331
        • Pfizer Investigational Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Pfizer Investigational Site
      • South Bend, Indiana, United States, 46601
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70815
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70002
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Pfizer Investigational Site
    • Michigan
      • Saginaw, Michigan, United States, 48602
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89109
        • Pfizer Investigational Site
      • North Las Vegas, Nevada, United States, 89030
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Pfizer Investigational Site
    • New York
      • Olean, New York, United States, 14760
        • Pfizer Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45220
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
      • Gallipolis, Ohio, United States, 45631
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78756
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78703
        • Pfizer Investigational Site
      • Bryan, Texas, United States, 77802-1903
        • Pfizer Investigational Site
      • Conroe, Texas, United States, 77304
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75061
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Pfizer Investigational Site
      • Morgantown, West Virginia, United States, 26506-9251
        • 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

Female

Description

Inclusion Criteria:

  • Female outpatients 18 years or older.
  • Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
  • Currently sexually active with a male partner.

Exclusion Criteria:

  • Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
  • Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
  • Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
  • Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.

Secondary Outcome Measures

Outcome Measure
Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline
Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
Reasons for treatment withdrawal
Adverse Events during the 24 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.

General Publications

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, 2005

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 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

  • A6121002

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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