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

Astellas Pharma Inc132 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

132

Conditions

Overactive Bladder

Interventions

solifenacinDRUG

Oral

oxybutynin immediate releaseDRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Unnamed facility

Calgary, Alberta, Canada

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

Victoria, British Columbia, Canada

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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