A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: Solifenacin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Kyu-Sung Lee, MD, Principal Investigator, Affiliation: University School of Medicine, Kangnan-ku, Seoul, Korea
Overall contact:
Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients with "add-on" solifenacin treatment
Secondary outcome: Change from baseline in micturition efficacy parameters
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
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com
Seoul, Korea, Republic of; Recruiting
Suwon, Korea, Republic of; Recruiting
Pusan, Korea, Republic of; Recruiting
Daegu, Korea, Republic of; Recruiting
Kwang-ju, Korea, Republic of; Recruiting
Cheon-ju, Korea, Republic of; Recruiting
Kangneung, Korea, Republic of; Recruiting
Choongju, Korea, Republic of; Recruiting
Daejeon, Korea, Republic of; Recruiting
Additional Information
Starting date: March 2009
Ending date: March 2010
Last updated: April 16, 2009
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