Urinary Incontinence
Conditions
Keywords
OAB, Overactive Bladder, Bladder hyperactivity, Urge Incontinence, Incontinence, Bladder
Brief summary
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
Interventions
DRUGDarifenacin
Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily
BEHAVIORALBehavioral therapy
Behavioral Modification Programme for symptoms of overactive bladder
Sponsors
Procter and Gamble
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Symptoms of overactive bladder * Capable of independent toileting and completing a micturition diary * Able to comprehend English and follow study procedures and instructions
Exclusion criteria
* Post void residual \> 100ml/sec * Urine flow rate (Qmax) \<10ml/sec for males only Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in average number of urinations per patient per day at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6 | — |
| Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12 | — |
| Quality of Life (baseline, Week 6, Week 12) | — |
Countries
United States
Outcome results
None listed