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

Condition(s) targeted: Overactive Bladder

Intervention: solifenacin (Drug); oxybutynin immediate release (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.

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).

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event

The Severity of Dry Mouth Reported as an Adverse Event

Secondary outcome:

Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary

Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary

Detailed 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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Calgary, Alberta T2V 4R6, Canada

Edmonton, Alberta T5H 3V9, Canada

Vancouver, British Columbia V6T 2B5, Canada

Victoria, British Columbia V8T 5G1, Canada

Halifax, Nova Scotia B3H 3A7, Canada

Guelph, Ontario N1H 5J1, Canada

Kitchener, Ontario N2N 2B9, Canada

Toronto, Ontario M4N 3M5, Canada

Toronto, Ontario M5G 1Z5, Canada

Toronto, Ontario M5T 2S8, Canada

Toronto, Ontario M6A 3B5, Canada

Montreal, Quebec H3T 1E2, Canada

Link to prescribing information

Related publications:

Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.

Starting date: December 2006
Last updated: June 1, 2010