A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

Study Overview
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Brief Summary
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The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.

Official Title
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A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: Alpha blocker
* Drug: placebo
* Drug: solifenacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by: symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and symptoms of urinary frequency ( >8 micturitions per 24 hours) On a stable dose of tamsulosin for at least 1 month Exclusion Criteria: Previous history of acute urinary retention Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention Symptomatic acute urinary tract infection (UTI) during the screening period Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder A 5-alpha reductase inhibitor if started less than 3 months prior to screening Patients with previous urethral, prostate or bladder neck surgery

Ages Eligible for Study
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Minimum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Alpha blocker and placebo<br> | Drug: Alpha blocker<br>* oral<br>Drug: placebo<br>* oral<br>|
| Experimental: Alpha blocker and solifenacin<br> | Drug: Alpha blocker<br>* oral<br>Drug: solifenacin<br>* oral<br>* Other names: YM905;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement level of patients' individual satisfaction |  | At weeks 4 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urgency episodes |  | At weeks 4 and 12 | 
| Changes in OAB symptom scores |  | At weeks 4 and 12 | 
| Changes in QoL score by OAB-q |  | At weeks 4 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence