Urinary Incontinence
Conditions
Brief summary
The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.
Interventions
DRUGTolterodine ER 4mg QD
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female outpatients 18 years or older. * Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months. * Currently sexually active with a male partner.
Exclusion criteria
* Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction. * Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator. * Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period. * Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline | — |
| Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline | — |
| Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline | — |
| Reasons for treatment withdrawal | — |
| Adverse Events during the 24 week treatment period. | — |
Countries
United States
Outcome results
None listed