overactive bladder (OAB)
Conditions
Interventions
Subjects receive fesoterodine 4 mg once daily for 4 weeks
thereafter, daily dosage is maintained at 4 mg or increased to 8 mg based on the subject'
s and physician'
s subjective assessment of efficacy and tolerability.
Sponsors
Department of Urology, Yotsuya Medical Cube
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.female adults with moderate/severe OAB(OABSS>=6) 2.Untreated OAB patients or OAB drug washout for at least 2 weeks before starting the treatment period. 3.Obtaining of written informed consent
Exclusion criteria
Exclusion criteria: 1.subject with the episode of urinary retention within 12 months. 2.subjects with post void residual more than 100ml. 3.subject with urinary catheter indwelled or subject under clean intermittent catheterization (CIC) 4.Acute urinary tract infection( more than 3 times within 1 year), history of urolithiasis and interstitial cystitis. 5.Polyuria(>=3000ml/day) 6.subjects who are contraindicated for fesoterodine administration. 7.Subject considered inappropriate for participating in the study by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in mean of urgency episodes per 24 hours after 12-week fesoterodine treatment. | — |
Countries
Japan
Contacts
Public ContactYasukuni Yoshimura
Yotsuya Medical Cube Department of Urology
Outcome results
None listed