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Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tolterodine ER 4 mg QD
OAB Patient Behavioral Training Material
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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female subjects greater than or equal to 18 years of age Overactive bladder symptoms for at least 3 months Previously treated with antimuscarinic OAB medications Exclusion Criteria: Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions

Sites / Locations

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

Outcomes

Primary Outcome Measures

Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question

Secondary Outcome Measures

Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
Reasons for treatment withdrawal.
Adverse events during the 16 week treatment period

Full Information

First Posted
September 29, 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
NCT00230789
Brief Title
Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
Official Title
A Multicenter, Multiphase, Single Arm, Open Label Study To Evaluate The Effects Of Tolterodine ER In Conjunction With Behavioral Intervention On Subject Satisfaction And Over- Active Bladder Symptoms (Urgency Urinary Incontinence (UUI), Urgency, Frequency) In Overactive Bladder Subjects Who Were Dissatisfied With Their Most Recent Antimuscarinic OAB Medication Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
417 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tolterodine ER 4 mg QD
Intervention Type
Behavioral
Intervention Name(s)
OAB Patient Behavioral Training Material
Primary Outcome Measure Information:
Title
Subject satisfaction with treatment at week 16: Percentage of subjects reporting satisfaction with their current OAB treatment using the Patient Perception of Treatment Satisfaction Question
Secondary Outcome Measure Information:
Title
Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Title
Percent subjects changed dissatisfied(including'very dissatisfied'and'a little dissatisfied')with OAB week 8 to satisfied(including'very satisfied' and'a little satisfied')with OAB week 16 measured by Patient Perception of Treatment Satisfaction Question
Title
Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Title
Change in mean number of urgency episodes per day at weeks 4, 8, 12 and 16 compared with baseline (Urgency episode defined as micturition episodes associated with Urinary Sensation Scale rating of greater than or equal to 3).
Title
Change in daily urgency micturition rating at weeks 4,8,12 and 16 compared with baseline:Change in mean and sum of Urinary Sensation Scale rating per day
Title
Change in mean number of micturition episodes per 24 hour period and per nocturnal period at weeks 4, 8, 12 and 16 compared with baseline. Means will be based on five dairy days. The following micturition episode parameters will be assessed:
Title
Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
Title
OAB micturition: Number of OAB mictruition episodes per time period (24 hour or nocturnal). OAB micturition defined as number of micturition episodes associated with Urinary Sensation Scale ratting of greater than or equal to 3
Title
Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Title
Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Title
Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Title
Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Title
Change in total Health Related Quality of Life (HRQoL) for Overactive Bladder Questionnaire (OAB-q) and change in scores for each individual domain (symptom bother, coping, concern, sleep, and social function) at weeks 8 and 16 compared with baseline
Title
Reasons for treatment withdrawal.
Title
Adverse events during the 16 week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects greater than or equal to 18 years of age Overactive bladder symptoms for at least 3 months Previously treated with antimuscarinic OAB medications Exclusion Criteria: Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions
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
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Sun Lakes
State/Province
Arizona
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Buena Park
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Modesto
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
Pfizer Investigational Site
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale Beach
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Georgia
Country
United States
Facility Name
Pfizer Investigational Site
City
Libertyville
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Mattoon
State/Province
Illinois
Country
United States
Facility Name
Pfizer Investigational Site
City
Newton
State/Province
Kansas
Country
United States
Facility Name
Pfizer Investigational Site
City
Milford
State/Province
Massachusetts
Country
United States
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Pfizer Investigational Site
City
Westhampton
State/Province
New Jersey
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Bronx
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Endwell
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden City
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Pfizer Investigational Site
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Zanesville
State/Province
Ohio
Country
United States
Facility Name
Pfizer Investigational Site
City
Norman
State/Province
Oklahoma
Country
United States
Facility Name
Pfizer Investigational Site
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Bala-Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Williamsport
State/Province
Pennsylvania
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Simpsonville
State/Province
South Carolina
Country
United States
Facility Name
Pfizer Investigational Site
City
Bartlett
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
New Tazewell
State/Province
Tennessee
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pfizer Investigational Site
City
Provo
State/Province
Utah
Country
United States
Facility Name
Pfizer Investigational Site
City
Mountlake Terrace
State/Province
Washington
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121146&StudyName=Effect+Of+Detrol+LA+with+Behavioral+Intervention+In+Overactive+Bladder+Subjects+Dissatisfied+with+Recent+OAB+Medication%2E
Description
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Learn more about this trial

Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

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