Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT00431041
- Lead Sponsor
- Astellas Pharma Inc
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxybutynin IR oxybutynin immediate release Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day Solifenacin solifenacin Solifenacin succinate: 5 mg tablets, taken orally, once daily
- Primary Outcome Measures
Name Time Method The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event 8 weeks The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
The Severity of Dry Mouth Reported as an Adverse Event 8 weeks 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)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary Baseline and 8 Weeks 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.Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary Baseline and 8 weeks 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.