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.

简要总结

主要结局

次要结局

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