Status:
COMPLETED
A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
Lead Sponsor:
KYU-SUNG LEE
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Overactive Bladder
Eligibility:
MALE
45+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.
Detailed Description
This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urge...
Eligibility Criteria
Inclusion
- IPSS ≥ 12
- Symptoms of OAB as verified by the V8 (≥8)
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Mean urinary frequency ≥8 times/24 hours
- Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)
Exclusion
- Treatment within the 14 days preceding treatment with any alpha blocker drugs
- A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00884104
Start Date
March 1 2009
End Date
December 1 2010
Last Update
January 7 2016
Active Locations (9)
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1
Cheonju, South Korea
2
Choongju, South Korea
3
Daegu, South Korea
4
Daejeon, South Korea