Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

• Drug: fesoterodine fumarate
  
  4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
• Drug: placebo
  
  once daily (OD)for 12 weeks
• Drug: tolterodine tartrate
  
  4 mg once daily (OD) for 12 weeks

• Experimental: Fesoterodine
  
  Tablets
  Intervention: Drug: fesoterodine fumarate
• Placebo Comparator: Placebo
  
  Tablets and capsules
  Intervention: Drug: placebo
• Active Comparator: Tolterodine
  
  Capsules
  Intervention: Drug: tolterodine tartrate

Inclusion Criteria:

• Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

• Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.