Urinary Incontinence
Conditions
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.
Interventions
BEHAVIORALOAB Patient Behavioral Training Material
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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: | — |
| 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). | — |
| Total micturitions: total number of micturition episodes per time period (24 hour or nocturnal) | — |
| 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 | — |
| 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 | — |
| Percentage of subjects reporting satisfaction (including 'very satisfied' and 'a little satisfied') with their current OAB treatment measured by Patient Perception of Treatment Satisfaction | — |
| 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 | — |
| Severe OAB micturitions in subjects with severe OAB micturition at baseline: Number of severe OAB micturition episodes per time period (24 hour or nocturnal). | — |
Countries
United States
Outcome results
None listed