Overactive Bladder Syndrome
Conditions
Keywords
Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
Brief summary
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.
Interventions
DRUGDarifenacin
Darifenacin 15 mg tablets once daily
DRUGPlacebo
Placebo tablets once daily
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2. * Patients capable of independent toileting and able of independently completing the patient diary.
Exclusion criteria
* Patients in whom the use of anticholinergic drugs was contraindicated * Evidence of severe liver disease * Patients with other clinically significant urinary or gynecological conditions Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in warning time at week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in frequency of urge incontinence episodes. | — |
| Change in frequency of micturitions. | — |
| Change in mean volume per void. | — |
| Change in warning time at weeks 2 & 6. | — |
| Safety and tolerability. | — |
| Quality of life. | — |
| Change in frequency of urgency. | — |
Countries
United States
Outcome results
None listed