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

Astellas

Status and phase

Completed

Phase 4

Conditions

Overactive Bladder

Treatments

Drug: solifenacin

Drug: oxybutynin immediate release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00431041

VES-001

Details and patient eligibility

About

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).

Full description

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).

Enrollment

132 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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