Overactive Bladder
Conditions
Keywords
Overactive Bladder
Brief summary
Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin
Interventions
DRUGDarifenacin (Emselex, BAY79-4998)
Patients in daily clinical treatment receiving Emselex according to local drug information
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients \> 18 years with symptoms of overactive bladder.
Exclusion criteria
* Contraindications for the treatment with Darifenacin prolonged-release tablets according to the registered package insert. * Pregnancy and lactation. Women of childbearing potential have to use an acceptable method of contraception. * Concomitant treatment with drugs known to affect mainly the urinary bladder function (e.g. anticholinergics, antispasmodics) at any time during the study. Concomitant treatment with botulinum toxin, capsaicin or resiniferatoxin at any time during the study and treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety and tolerability of Darifenacin in the daily practice for the treatment of the OAB (Over Active Bladder) syndrome. | 3 months later |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the patient's perception of bladder condition, the patient's use of the patient support program, the patient's and physician's assessment of treatment regarding efficacy and tolerability and patient's compliance with the treatment | 3 months later |
Countries
South Africa
Outcome results
None listed