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

Pfizer

Status: Completed

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Drug: fesoterodine

Study type: Observational

Funder types: Industry

Identifiers

NCT00691093

A0221059

Details and patient eligibility

About

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.

Full description

patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Enrollment: 823 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

823 participants in 1 patient group

fesoterodine

Treatment:

Drug: fesoterodine