Urinary Bladder, Overactive
Conditions
Keywords
Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
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.
Interventions
DRUGsolifenacin succinate
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms | Weeks 4, 8 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients satisfied with 5mg treatment | Week 12 |
| Percentage of patients obtaining additional benefit with increase to 10mg dose | week 12 |
Countries
United States
Outcome results
None listed