Status:
COMPLETED
Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Urinary Incontinence
Eligibility:
All Genders
18+ years
Brief Summary
This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the eff...
Detailed Description
patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Eligibility Criteria
Inclusion
- Patients older than 18 years
- Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
- Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
- Due to intolerance: persistent and/or unacceptable adverse events
Exclusion
- Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
- History of acute urinary retention (requiring catheterisation)
- Gastric retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child Pugh C)
- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
- Severe ulcerative colitis
- Toxic megacolon.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
823 Patients enrolled
Trial Details
Trial ID
NCT00691093
Start Date
July 1 2008
End Date
June 1 2009
Last Update
November 2 2018
Active Locations (65)
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1
Pfizer Investigational Site
?a?a, Slovakia
2
Pfizer Investigational Site
Aa, Slovakia
3
Pfizer Investigational Site
Adca, Slovakia
4
Pfizer Investigational Site
B.Bystrica, Slovakia