Back to resultsA Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Solifenacin
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Solifenacin, Tamsulosin, OAB
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1.tamsulosin + solifenacin
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with "add-on" solifenacin treatment
Secondary Outcome Measures
Change from baseline in micturition efficacy parameters
Full Information
NCT ID
NCT00884104
First Posted
March 25, 2009
Last Updated
January 6, 2016
Sponsor
KYU-SUNG LEE
Collaborators
Astellas Pharma Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00884104
Brief Title
A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
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 Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
KYU-SUNG LEE
Collaborators
Astellas Pharma Korea, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Solifenacin, Tamsulosin, OAB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.tamsulosin + solifenacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Percentage of patients with "add-on" solifenacin treatment
Time Frame
Weeks of 12, 24 and 52 of combination therapy
Secondary Outcome Measure Information:
Title
Change from baseline in micturition efficacy parameters
Time Frame
Weeks of 12, 24 and 52 of combination therapy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, MD
Organizational Affiliation
University School of Medicine, Kangnan-ku, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
City
Cheon-ju
Country
Korea, Republic of
City
Choongju
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Kangneung
Country
Korea, Republic of
City
Kwang-ju
Country
Korea, Republic of
City
Pusan
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25363606
Citation
Lee HN, Lee KS, Kim JC, Chung BH, Kim CS, Lee JG, Kim DK, Park CH, Park JK, Hong SJ. Rate and associated factors of solifenacin add-on after tamsulosin monotherapy in men with voiding and storage lower urinary tract symptoms. Int J Clin Pract. 2015 Apr;69(4):444-53. doi: 10.1111/ijcp.12581. Epub 2014 Nov 1.
Results Reference
derived
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A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
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