Status:
COMPLETED
A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe B.V.
Conditions:
Overactive Bladder
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessin...
Detailed Description
Subjects are screened between day -14 and day -1. At day 0 subjects will enter a randomized, parallel group study. After fulfilling all selection criteria, subjects will be randomized to one of two t...
Eligibility Criteria
Inclusion
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\> 3 months
Exclusion
- Clinically significant outflow obstruction
- Significant post void residual volume
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator.
- Patient with a neurological cause for abnormal detrusor activity.
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00337558
Start Date
May 1 2006
End Date
May 1 2007
Last Update
September 18 2014
Active Locations (64)
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1
Kogarah, New South Wales, Australia, 2217
2
Randwick, New South Wales, Australia, 2031
3
Auchenflower, Queensland, Australia, 4066
4
Clayton, Victoria, Australia, 3168