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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tolterodine ER 4 mg QD
Tamsulosin 0.4 mg QD
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00147654
Brief Title
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
830 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tolterodine ER 4 mg QD
Intervention Type
Drug
Intervention Name(s)
Tamsulosin 0.4 mg QD
Primary Outcome Measure Information:
Title
Patient Perception of Treatment Benefit at Week 12:
Title
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
Secondary Outcome Measure Information:
Title
Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Title
Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
Title
Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
Title
Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Title
Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
Title
Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
International Prostate Symptom Score (I-PSS):
Title
Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
Title
Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
Title
Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
Title
Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
Title
Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
Title
Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
Title
Patient perception of urgency:
Title
Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
Title
Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
Title
Patient Perception of Treatment benefit at week 1 and week 6
Title
Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
Title
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
Title
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
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
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United States
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Pfizer Investigational Site
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Homewood
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Alabama
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United States
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Pfizer Investigational Site
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Tucson
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Arizona
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United States
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Pfizer Investigational Site
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Anaheim
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California
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United States
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Pfizer Investigational Site
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Culver City
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California
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United States
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Pfizer Investigational Site
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Fresno
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California
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United States
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Pfizer Investigational Site
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La Mesa
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California
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United States
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Pfizer Investigational Site
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Long Beach
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California
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United States
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Pfizer Investigational Site
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Los Angeles
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California
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United States
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Pfizer Investigational Site
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Murrieta
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California
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United States
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Pfizer Investigational Site
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Poway
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California
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United States
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Pfizer Investigational Site
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San Bernardino
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California
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United States
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Pfizer Investigational Site
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Santa Monica
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California
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United States
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Pfizer Investigational Site
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Aurora
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Colorado
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Pfizer Investigational Site
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Boulder
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Colorado
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United States
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Pfizer Investigational Site
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Denver
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Colorado
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Pfizer Investigational Site
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New Britain
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Connecticut
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United States
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Pfizer Investigational Site
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Waterbury
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Connecticut
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United States
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Pfizer Investigational Site
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Melbourne
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United States
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Pfizer Investigational Site
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Ocala
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Pfizer Investigational Site
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Pembroke Pines
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United States
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Pfizer Investigational Site
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Tallahassee
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Pfizer Investigational Site
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Wellington
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Pfizer Investigational Site
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Atlanta
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Georgia
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Pfizer Investigational Site
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Columbus
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Georgia
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Pfizer Investigational Site
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Roswell
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Georgia
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United States
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Pfizer Investigational Site
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Melrose Park
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Illinois
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Pfizer Investigational Site
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Evansville
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Indiana
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United States
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Pfizer Investigational Site
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Jeffersonville
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Indiana
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United States
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Pfizer Investigational Site
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Iowa City
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Iowa
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Pfizer Investigational Site
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Overland Park
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United States
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Pfizer Investigational Site
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Shreveport
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Pfizer Investigational Site
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Boston
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United States
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Pfizer Investigational Site
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Brighton
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United States
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Pfizer Investigational Site
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Watertown
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United States
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Pfizer Investigational Site
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Columbia
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Pfizer Investigational Site
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O'Fallon
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Pfizer Investigational Site
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Saint Louis
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Missouri
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United States
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Pfizer Investigational Site
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Missoula
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Montana
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United States
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Pfizer Investigational Site
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Henderson
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Nevada
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Pfizer Investigational Site
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Las Vegas
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Nevada
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Pfizer Investigational Site
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Cherry Hill
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United States
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Pfizer Investigational Site
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Edison
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Pfizer Investigational Site
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Hamilton
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Pfizer Investigational Site
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Lawrenceville
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New Jersey
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Pfizer Investigational Site
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Marlton
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New Jersey
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United States
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Pfizer Investigational Site
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Mount Laurel
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New Jersey
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United States
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Pfizer Investigational Site
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Sewell
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New Jersey
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United States
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Pfizer Investigational Site
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Voorhees
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New Jersey
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United States
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Pfizer Investigational Site
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Westhampton
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New Jersey
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United States
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Pfizer Investigational Site
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Woodbury
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New Jersey
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United States
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Pfizer Investigational Site
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Albuquerque
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New Mexico
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United States
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Pfizer Investigational Site
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Albany
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New York
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United States
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Pfizer Investigational Site
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Bay Shore
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New York
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United States
Facility Name
Pfizer Investigational Site
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Carmel
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New York
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United States
Facility Name
Pfizer Investigational Site
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Cortlandt Manor
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New York
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United States
Facility Name
Pfizer Investigational Site
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Garden City
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New York
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United States
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Pfizer Investigational Site
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Manhasset
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New York
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United States
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Pfizer Investigational Site
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New York
State/Province
New York
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United States
Facility Name
Pfizer Investigational Site
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Orchard Park
State/Province
New York
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Facility Name
Pfizer Investigational Site
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Poughkeepsie
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New York
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Pfizer Investigational Site
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Staten Island
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New York
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United States
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Pfizer Investigational Site
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Syracuse
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New York
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United States
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Pfizer Investigational Site
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Cincinnati
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Ohio
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Pfizer Investigational Site
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Cleveland
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United States
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Pfizer Investigational Site
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Columbus
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Pfizer Investigational Site
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Oklahoma City
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Oklahoma
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Pfizer Investigational Site
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Portland
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United States
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Pfizer Investigational Site
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Allentown
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United States
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Pfizer Investigational Site
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Bala-Cynwyd
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United States
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Pfizer Investigational Site
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Bryn Mawr
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Pennsylvania
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United States
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Pfizer Investigational Site
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Philadelphia
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United States
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Pfizer Investigational Site
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State College
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Pennsylvania
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United States
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Pfizer Investigational Site
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Wynnewood
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Pennsylvania
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United States
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Pfizer Investigational Site
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Providence
State/Province
Rhode Island
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United States
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Pfizer Investigational Site
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Charleston
State/Province
South Carolina
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United States
Facility Name
Pfizer Investigational Site
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Greenwood
State/Province
South Carolina
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United States
Facility Name
Pfizer Investigational Site
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Greer
State/Province
South Carolina
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United States
Facility Name
Pfizer Investigational Site
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Prosperity
State/Province
South Carolina
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United States
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Pfizer Investigational Site
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Saluda
State/Province
South Carolina
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United States
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Pfizer Investigational Site
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Germantown
State/Province
Tennessee
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United States
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Pfizer Investigational Site
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Milan
State/Province
Tennessee
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United States
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Pfizer Investigational Site
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Arlington
State/Province
Texas
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United States
Facility Name
Pfizer Investigational Site
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Austin
State/Province
Texas
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United States
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Pfizer Investigational Site
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Houston
State/Province
Texas
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United States
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Pfizer Investigational Site
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San Antonio
State/Province
Texas
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United States
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Pfizer Investigational Site
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Provo
State/Province
Utah
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United States
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Pfizer Investigational Site
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Alexandria
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
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Arlington
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
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Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
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Fairfax
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
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Virginia Beach
State/Province
Virginia
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United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
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Tacoma
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Cheyenne
State/Province
Wyoming
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17105794
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121120&StudyName=Effect+and+Safety+Of+Detrol+LA+In+Men+With+Overactive+Bladder+Symptoms+With+Or+Without+Bladder+Outlet+Obstruction
Description
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Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

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