Overactive Bladder Syndrome
Conditions
Keywords
Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
Brief summary
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
Interventions
DRUGDarifenacin
Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Adult patients with overactive bladder who completed a previous darifenacin short-term trial. * 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 |
|---|---|
| Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight. | — |
Secondary
| Measure | Time frame |
|---|---|
| Long term efficacy on the symptoms of overactive bladder | — |
| King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24), | — |
Countries
United States
Outcome results
None listed