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

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Solifenacin

• Registration Number: NCT00884104
• Lead Sponsor: KYU-SUNG LEE

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 urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-20
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 307

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.tamsulosin + solifenacin	Solifenacin	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with "add-on" solifenacin treatment	Weeks of 12, 24 and 52 of combination therapy

Secondary Outcome Measures

Name	Time	Method
Change from baseline in micturition efficacy parameters	Weeks of 12, 24 and 52 of combination therapy