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

Urinary Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230789
• Other study ID #: A6121146
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• Tolterodine ER 4 mg QD

Behavioral:
• OAB Patient Behavioral Training Material

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Abington	Pennsylvania
United States	Pfizer Investigational Site	Albany	New York
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Bala-Cynwyd	Pennsylvania
United States	Pfizer Investigational Site	Bartlett	Tennessee
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Buena Park	California
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Canton	Ohio
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Endwell	New York
United States	Pfizer Investigational Site	Garden City	New York
United States	Pfizer Investigational Site	Greensboro	North Carolina
United States	Pfizer Investigational Site	Hallandale Beach	Florida
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Johnson City	Tennessee
United States	Pfizer Investigational Site	Libertyville	Illinois
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Manchester	Missouri
United States	Pfizer Investigational Site	Mattoon	Illinois
United States	Pfizer Investigational Site	Milford	Massachusetts
United States	Pfizer Investigational Site	Mission Viejo	California
United States	Pfizer Investigational Site	Modesto	California
United States	Pfizer Investigational Site	Mount Pleasant	South Carolina
United States	Pfizer Investigational Site	Mountlake Terrace	Washington
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	Newton	Kansas
United States	Pfizer Investigational Site	Norman	Oklahoma
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Paramount	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	Provo	Utah
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Simpsonville	South Carolina
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Sun Lakes	Arizona
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Tustin	California
United States	Pfizer Investigational Site	Wellington	Florida
United States	Pfizer Investigational Site	Westhampton	New Jersey
United States	Pfizer Investigational Site	Wheat Ridge	Colorado
United States	Pfizer Investigational Site	Williamsport	Pennsylvania
United States	Pfizer Investigational Site	Woodstock	Georgia
United States	Pfizer Investigational Site	Zanesville	Ohio

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	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	Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction
Secondary	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
Secondary	Change in mean number of urgency urinary incontinence episodes at weeks 4, 8, 12 and 16 compared with baseline
Secondary	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).
Secondary	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
Secondary	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:
Secondary	Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal)
Secondary	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
Secondary	Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal).
Secondary	Severe OAB micturition episodes defined as number of micturitions associated with a Urinary Sensation Scale rating of greater than or equal to 4
Secondary	Change in Patient Perception of Bladder Condition (PPBC) at weeks 8 and 16 compared with baseline
Secondary	Change in Patient Perception of Urgency Scale (PPUS) at weeks 8 and 16 compared with baseline
Secondary	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
Secondary	Reasons for treatment withdrawal.
Secondary	Adverse events during the 16 week treatment period

External Links

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