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

Overactive Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00431041
• Other study ID #: VES-001
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2007
• Last updated: June 1, 2010
• Start date: December 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin
Oral
• oxybutynin immediate release
Oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event	The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit	8 weeks	Yes
Primary	The Severity of Dry Mouth Reported as an Adverse Event	The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE).; Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) & "severe" (very dry mouth & throat, difficulty swallowing solid food without water)	8 weeks	Yes
Secondary	Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary	Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet.; The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.	Baseline and 8 Weeks	No
Secondary	Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary	Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine.; The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.	Baseline and 8 weeks	No

External Links

•   Link to prescribing information