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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.tamsulosin + solifenacin<br> | Drug: Solifenacin<br>* Oral<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solifenacin, Tamsulosin, OAB