Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
- Registration Number
- NCT00463541
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).
- Detailed Description
Study included a 24 week extension that did not occur due to FDA approval of the product.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2225
Inclusion Criteria
- Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months.
- Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.
Exclusion Criteria
- -Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction (benign prostatic hyperplasia)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 solifenacin succinate -
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms Weeks 4, 8 and 12
- Secondary Outcome Measures
Name Time Method Percentage of patients obtaining additional benefit with increase to 10mg dose week 12 Percentage of patients satisfied with 5mg treatment Week 12