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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884104
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : January 7, 2016
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

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 Type : Interventional  (Clinical Trial)
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 : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1.tamsulosin + solifenacin Drug: Solifenacin
Other Name: Vesicare

Primary Outcome Measures :
  1. Percentage of patients with "add-on" solifenacin treatment [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ]

Secondary Outcome Measures :
  1. Change from baseline in micturition efficacy parameters [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884104

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 Korea, Inc.
Principal Investigator: Kyu-Sung Lee, MD University School of Medicine, Kangnan-ku, Seoul, Korea

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center Identifier: NCT00884104     History of Changes
Other Study ID Numbers: SMK-3
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents