Status:
COMPLETED
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
Lead Sponsor:
KYU-SUNG LEE
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Urinary Bladder, Overactive
Eligibility:
MALE
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
Eligibility Criteria
Inclusion
- Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of \>=3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency ( \>8 micturitions per 24 hours)
- On a stable dose of tamsulosin for at least 1 month
Exclusion
- Previous history of acute urinary retention
- Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the screening period
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
- A 5-alpha reductase inhibitor if started less than 3 months prior to screening
- Patients with previous urethral, prostate or bladder neck surgery
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00699049
Start Date
June 1 2008
End Date
March 1 2010
Last Update
January 7 2016
Active Locations (3)
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1
Cheonan, South Korea
2
Pusan, South Korea
3
Seoul, South Korea