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

January 6, 2016 updated by: KYU-SUNG LEE

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

307

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with "add-on" solifenacin treatment
Time Frame: Weeks of 12, 24 and 52 of combination therapy
Weeks of 12, 24 and 52 of combination therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in micturition efficacy parameters
Time Frame: Weeks of 12, 24 and 52 of combination therapy
Weeks of 12, 24 and 52 of combination therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KYU-SUNG LEE

Collaborators

Astellas Pharma Korea, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMK-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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