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NCT00147654 Clinical Trial

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

Urinary Incontinence Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147654
Other study ID # A6121120
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2004
Est. completion date May 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 830
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tolterodine ER 4 mg QD

• Tamsulosin 0.4 mg QD

Locations
Country Name City State
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Alexandria Virginia
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Arlington Virginia
United States Pfizer Investigational Site Arlington Texas
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Bala-Cynwyd Pennsylvania
United States Pfizer Investigational Site Bay Shore New York
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boulder Colorado
United States Pfizer Investigational Site Brighton Massachusetts
United States Pfizer Investigational Site Bryn Mawr Pennsylvania
United States Pfizer Investigational Site Carmel New York
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Cherry Hill New Jersey
United States Pfizer Investigational Site Cheyenne Wyoming
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Columbia Missouri
United States Pfizer Investigational Site Columbus Georgia
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Cortlandt Manor New York
United States Pfizer Investigational Site Culver City California
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Edison New Jersey
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Fairfax Virginia
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Garden City New York
United States Pfizer Investigational Site Germantown Tennessee
United States Pfizer Investigational Site Greenwood South Carolina
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Hamilton New Jersey
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Homewood Alabama
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Iowa City Iowa
United States Pfizer Investigational Site Jeffersonville Indiana
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Lawrenceville New Jersey
United States Pfizer Investigational Site Long Beach California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Manhasset New York
United States Pfizer Investigational Site Marlton New Jersey
United States Pfizer Investigational Site Melbourne Florida
United States Pfizer Investigational Site Melrose Park Illinois
United States Pfizer Investigational Site Milan Tennessee
United States Pfizer Investigational Site Missoula Montana
United States Pfizer Investigational Site Mount Laurel New Jersey
United States Pfizer Investigational Site Murrieta California
United States Pfizer Investigational Site New Britain Connecticut
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site O'Fallon Missouri
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Orchard Park New York
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Poughkeepsie New York
United States Pfizer Investigational Site Poway California
United States Pfizer Investigational Site Prosperity South Carolina
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Provo Utah
United States Pfizer Investigational Site Roswell Georgia
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site Saluda South Carolina
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Bernardino California
United States Pfizer Investigational Site Santa Monica California
United States Pfizer Investigational Site Sewell New Jersey
United States Pfizer Investigational Site Shreveport Louisiana
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site State College Pennsylvania
United States Pfizer Investigational Site Staten Island New York
United States Pfizer Investigational Site Syracuse New York
United States Pfizer Investigational Site Tacoma Washington
United States Pfizer Investigational Site Tallahassee Florida
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Virginia Beach Virginia
United States Pfizer Investigational Site Voorhees New Jersey
United States Pfizer Investigational Site Waterbury Connecticut
United States Pfizer Investigational Site Watertown Massachusetts
United States Pfizer Investigational Site Wellington Florida
United States Pfizer Investigational Site Westhampton New Jersey
United States Pfizer Investigational Site Woodbury New Jersey
United States Pfizer Investigational Site Wynnewood Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Perception of Treatment Benefit at Week 12:
Primary Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
Secondary Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Secondary Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Secondary Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
Secondary Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Secondary Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Secondary Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary International Prostate Symptom Score (I-PSS):
Secondary Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
Secondary Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
Secondary Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
Secondary Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
Secondary Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
Secondary Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
Secondary Patient perception of urgency:
Secondary Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
Secondary Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
Secondary Patient Perception of Treatment benefit at week 1 and week 6
Secondary Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
Secondary 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
Secondary 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
Secondary 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
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