Overactive Bladder (OAB)
Conditions
Keywords
Darifenacin,Overactive Bladder,antimuscarinic,M3 muscarinic receptor antagonist
Brief summary
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.
Interventions
DRUGDarifenacin
Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily
Sponsors
Procter and Gamble
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
* • Symptoms of OAB for at least six months prior to randomization * ≥ 8 micturitions on average/24 hours * ≥ 1 urgency episodes on average/24 hours * with or without UUIE * Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken. * Patients without prior darifenacin treatment
Exclusion criteria
* • A mean daily urinary volume \>3000 mL or a mean volume voided/micturition of \>300 mL as verified in the micturition diary for two consecutive days prior to Baseline * Males with post-void residual (PVR) urinary volume \>200 mL at Baseline * Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator * Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator Other protocol-defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13. | — |
| Assessment of efficacy of darifenacin with respect to change from baseline in: | — |
| Number of micturitions per day at Weeks 7 and 13 | — |
| Patient's perception of outcome using the PPBC questionnaire at Week 7. | — |
| Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13 | — |
| Assessment of safety and tolerability | — |
| Number of urgency episodes per day at Weeks 7 and 13 | — |
Countries
United States
Outcome results
None listed