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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: solifenacin
* Drug: oxybutynin immediate release


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solifenacin<br>Solifenacin succinate: 5 mg tablets, taken orally, once daily | Drug: solifenacin<br>* Oral<br>* Other names: YM905;|
| Active Comparator: Oxybutynin IR<br>Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day | Drug: oxybutynin immediate release<br>* Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xerostomia, Solifenacin succinate, Oxybutynin immediate release, Overactive bladder