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

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: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Drug: Tolterodine ER 4 mg QD; Drug: Tamsulosin 0.4 mg QD

• Study Type: Interventional
• Enrollment: 830
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

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
Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary Outcome Measures

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

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

Publications and helpful links

General Publications

• Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319. Erratum In: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 7, 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: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urethral Diseases; Urethral Obstruction; Urinary Incontinence; Urinary Bladder Neck Obstruction; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Tolterodine Tartrate
• Other Study ID Numbers: A6121120