Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

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

A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction

The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
830

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Pfizer Investigational Site
      • Homewood, Alabama, United States
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, United States
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States
        • Pfizer Investigational Site
      • Culver City, California, United States
        • Pfizer Investigational Site
      • Fresno, California, United States
        • Pfizer Investigational Site
      • La Mesa, California, United States
        • Pfizer Investigational Site
      • Long Beach, California, United States
        • Pfizer Investigational Site
      • Los Angeles, California, United States
        • Pfizer Investigational Site
      • Murrieta, California, United States
        • Pfizer Investigational Site
      • Poway, California, United States
        • Pfizer Investigational Site
      • San Bernardino, California, United States
        • Pfizer Investigational Site
      • Santa Monica, California, United States
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States
        • Pfizer Investigational Site
      • Boulder, Colorado, United States
        • Pfizer Investigational Site
      • Denver, Colorado, United States
        • Pfizer Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States
        • Pfizer Investigational Site
    • Florida
      • Melbourne, Florida, United States
        • Pfizer Investigational Site
      • Ocala, Florida, United States
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States
        • Pfizer Investigational Site
      • Wellington, Florida, United States
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pfizer Investigational Site
      • Columbus, Georgia, United States
        • Pfizer Investigational Site
      • Roswell, Georgia, United States
        • Pfizer Investigational Site
    • Illinois
      • Melrose Park, Illinois, United States
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • Pfizer Investigational Site
      • Jeffersonville, Indiana, United States
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Pfizer Investigational Site
      • Brighton, Massachusetts, United States
        • Pfizer Investigational Site
      • Watertown, Massachusetts, United States
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States
        • Pfizer Investigational Site
      • O'Fallon, Missouri, United States
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States
        • Pfizer Investigational Site
    • Montana
      • Missoula, Montana, United States
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States
        • Pfizer Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States
        • Pfizer Investigational Site
      • Edison, New Jersey, United States
        • Pfizer Investigational Site
      • Hamilton, New Jersey, United States
        • Pfizer Investigational Site
      • Lawrenceville, New Jersey, United States
        • Pfizer Investigational Site
      • Marlton, New Jersey, United States
        • Pfizer Investigational Site
      • Mount Laurel, New Jersey, United States
        • Pfizer Investigational Site
      • Sewell, New Jersey, United States
        • Pfizer Investigational Site
      • Voorhees, New Jersey, United States
        • Pfizer Investigational Site
      • Westhampton, New Jersey, United States
        • Pfizer Investigational Site
      • Woodbury, 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
      • Bay Shore, New York, United States
        • Pfizer Investigational Site
      • Carmel, New York, United States
        • Pfizer Investigational Site
      • Cortlandt Manor, New York, United States
        • Pfizer Investigational Site
      • Garden City, New York, United States
        • Pfizer Investigational Site
      • Manhasset, New York, United States
        • Pfizer Investigational Site
      • New York, New York, United States
        • Pfizer Investigational Site
      • Orchard Park, New York, United States
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States
        • Pfizer Investigational Site
      • Staten Island, New York, United States
        • Pfizer Investigational Site
      • Syracuse, New York, United States
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States
        • Pfizer Investigational Site
      • Columbus, Ohio, United States
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Pfizer Investigational Site
      • Bala-Cynwyd, Pennsylvania, United States
        • Pfizer Investigational Site
      • Bryn Mawr, Pennsylvania, United States
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States
        • Pfizer Investigational Site
      • State College, Pennsylvania, United States
        • Pfizer Investigational Site
      • Wynnewood, Pennsylvania, United States
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Pfizer Investigational Site
      • Greenwood, South Carolina, United States
        • Pfizer Investigational Site
      • Greer, South Carolina, United States
        • Pfizer Investigational Site
      • Prosperity, South Carolina, United States
        • Pfizer Investigational Site
      • Saluda, South Carolina, United States
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States
        • Pfizer Investigational Site
      • Milan, Tennessee, United States
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States
        • Pfizer Investigational Site
      • Austin, Texas, United States
        • Pfizer Investigational Site
      • Houston, Texas, United States
        • Pfizer Investigational Site
      • San Antonio, Texas, United States
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, United States
        • Pfizer Investigational Site
    • Virginia
      • Alexandria, Virginia, United States
        • Pfizer Investigational Site
      • Arlington, Virginia, United States
        • Pfizer Investigational Site
      • Charlottesville, Virginia, United States
        • Pfizer Investigational Site
      • Fairfax, Virginia, United States
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States
        • Pfizer Investigational Site
      • Tacoma, Washington, United States
        • Pfizer Investigational Site
    • Wyoming
      • Cheyenne, Wyoming, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male 40 years of age
  • Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
  • Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

  • Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound
  • Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
  • Prescribed and administered an antimuscarinic or antispasmodic within 1 month
  • Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
Change in number of OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
Change in number of daytime OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
Change in number of nighttime OAB micturition episodes per 24 hours. (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of daytime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
Change in number of nighttime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
International Prostate Symptom Score (I-PSS):
Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
Patient perception of urgency:
Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
Patient Perception of Treatment benefit at week 1 and week 6
Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
Change in International Continence Society Male (ICSmaleLF) Questionnaire (long form modified) individual item scores at Week 1, Week 6 and Week 12 relative to baseline
Change in the total score of Overactive Bladder Questionnaire (OABq) and change in total scores for each domain of OABq at week 6 and week 12 relative to baseline
Change in the total score of International Index of Erectile Function (IIEF) and change in total scores for each domain of IIEF Questionnaire at week 6 and week 12 relative to baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6121120

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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