Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.
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.
1 other identifier
interventional
417
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 27, 2021
January 1, 2021
1.2 years
September 29, 2005
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
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
- +10 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Sun Lakes, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Beverly Hills, California, United States
Pfizer Investigational Site
Buena Park, California, United States
Pfizer Investigational Site
Mission Viejo, California, United States
Pfizer Investigational Site
Modesto, California, United States
Pfizer Investigational Site
Oceanside, California, United States
Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Tustin, California, United States
Pfizer Investigational Site
Colorado Springs, Colorado, United States
Pfizer Investigational Site
Wheat Ridge, Colorado, United States
Pfizer Investigational Site
Hallandale, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Wellington, Florida, United States
Pfizer Investigational Site
Woodstock, Georgia, United States
Pfizer Investigational Site
Libertyville, Illinois, United States
Pfizer Investigational Site
Mattoon, Illinois, United States
Pfizer Investigational Site
Newton, Kansas, United States
Pfizer Investigational Site
Milford, Massachusetts, United States
Pfizer Investigational Site
Manchester, Missouri, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Westhampton, New Jersey, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
Albany, New York, United States
Pfizer Investigational Site
Endwell, New York, United States
Pfizer Investigational Site
Garden City, New York, United States
Pfizer Investigational Site
Poughkeepsie, New York, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Greensboro, North Carolina, United States
Pfizer Investigational Site
Hickory, North Carolina, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Canton, Ohio, United States
Pfizer Investigational Site
Zanesville, Ohio, United States
Pfizer Investigational Site
Norman, Oklahoma, United States
Pfizer Investigational Site
Abington, Pennsylvania, United States
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, United States
Pfizer Investigational Site
Camp Hill, Pennsylvania, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Williamsport, Pennsylvania, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States
Pfizer Investigational Site
Simpsonville, South Carolina, United States
Pfizer Investigational Site
Bartlett, Tennessee, United States
Pfizer Investigational Site
Johnson City, Tennessee, United States
Pfizer Investigational Site
New Tazewell, Tennessee, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Provo, Utah, United States
Pfizer Investigational Site
Mountlake Terrace, Washington, United States
Pfizer Investigational Site
Spokane, Washington, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2005
First Posted
October 3, 2005
Study Start
October 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 27, 2021
Record last verified: 2021-01