NCT00884104

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

A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: KYU-SUNG LEE · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Solifenacin	Oral

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-04-20
• Last updated: 2016-01-07

Locations

9 sites across 1 country: South Korea