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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Drug: Tolterodine ER 4 mg QD
* Behavioral: OAB Patient Behavioral Training Material


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tolterodine ER 4 mg QD|nan|
|Behavioral: OAB Patient Behavioral Training Material|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |