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

Sponsor

KYU-SUNG LEE (Other)

Overall Status

Completed

CT.gov ID

NCT00884104

Collaborator

Astellas Pharma Korea, Inc. (Industry)

307

Enrollment

Locations

Arm

Duration (Months)

34.1

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Solifenacin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

307 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.tamsulosin + solifenacin	Drug: Solifenacin Oral Other Names: Vesicare

Arm

Intervention/Treatment

Experimental: 1.tamsulosin + solifenacin

Drug: Solifenacin

Oral

Other Names:

Vesicare

Outcome Measures

Primary Outcome Measures

Percentage of patients with "add-on" solifenacin treatment [Weeks of 12, 24 and 52 of combination therapy]

Secondary Outcome Measures

Change from baseline in micturition efficacy parameters [Weeks of 12, 24 and 52 of combination therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Cheon-ju	Korea, Republic of
2	Choongju	Korea, Republic of
3	Daegu	Korea, Republic of
4	Daejeon	Korea, Republic of
5	Kangneung	Korea, Republic of
6	Kwang-ju	Korea, Republic of
7	Pusan	Korea, Republic of
8	Seoul	Korea, Republic of
9	Suwon	Korea, Republic of