Clinical trial NCT00431041: Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Solifenacin succinate
Oxybutynin immediate release
Xerostomia
Overactive bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Canada, Inc.
First posted: 2007-02-02
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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).

Eligibility 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

Primary outcomes:
measure: The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
timeFrame: 8 weeks
measure: The Severity of Dry Mouth Reported as an Adverse Event
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
timeFrame: Baseline and 8 Weeks
measure: Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Guelph
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma Canada, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.
citation: Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.