Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Inclusion Criteria:

• Adults 18 years and older.
• Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria:

• Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
• Clinically significant outflow obstruction
• Uncontrolled narrow angle glaucoma, urinary, or gastric retention
• Severe renal or hepatic impairment
• Chronic severe constipation or history of diagnosed GI obstructive disease
• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
• Diagnosis or history of neurogenic bladder
• History of bladder or pelvic cancer