Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 efficacy and tolerability of fesoterodine.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fesoterodine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.