A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients
Phase 3
Completed
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Registration Number
- NCT00368706
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
Inclusion Criteria
- Patients willing and able to complete the micturition diary correctly
- Patients experiencing frequency of micturition as verified in the diary
- Patients experiencing significant post void residual volume
- OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.
Exclusion Criteria
- Significant post void residual volume
- Patients with indwelling catheters or practicing intermittent self- catheterization
- Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 solifenacin succinate - 2 tolterodine -
- Primary Outcome Measures
Name Time Method Change from baseline in mean number of micturitions per 24 hours 8 Weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in mean volume voided per micturition 8 Weeks Change from baseline in mean number of incontinence episodes per 24 hours 8 Weeks Change from baseline in mean urgency frequency per 24 hours 8 Weeks Change from baseline in mean nocturia episodes per 24 hours 8 Weeks