A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KYU-SUNG LEE
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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