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

This study has been completed.

First Received on March 25, 2009. Last Updated on October 11, 2011 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborators:	Astellas Pharma Korea, Inc. Sungkyunkwan University School of Medicine
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00884104

Purpose

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	Intervention	Phase
Overactive Bladder	Drug: Solifenacin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Percentage of patients with "add-on" solifenacin treatment [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in micturition efficacy parameters [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ] [ Designated as safety issue: No ]

Enrollment:	307
Study Start Date:	March 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1.tamsulosin + solifenacin	Drug: Solifenacin Oral Other Name: Vesicare

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884104

Locations

Korea, Republic of

Cheon-ju, Korea, Republic of

Choongju, Korea, Republic of

Daegu, Korea, Republic of

Daejeon, Korea, Republic of

Kangneung, Korea, Republic of

Kwang-ju, Korea, Republic of

Pusan, Korea, Republic of

Seoul, Korea, Republic of

Suwon, Korea, Republic of

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Sungkyunkwan University School of Medicine

Investigators

Principal Investigator:

Kyu-Sung Lee, MD

University School of Medicine, Kangnan-ku, Seoul, Korea

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00884104 History of Changes
Other Study ID Numbers:	SMK-3
Study First Received:	March 25, 2009
Last Updated:	October 11, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Solifenacin
Tamsulosin
OAB

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012