Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Detailed Description
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Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride

Conditions
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Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder

Intervention / Treatment
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* Drug: Tamsulosin hydrochloride
* Drug: Solifenacin succinate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks Patients with urgency episodes and frequent micturitions Written informed consent has been obtained Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL Exclusion Criteria: Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.) Patients with obvious stress urinary incontinence Patients with complications or who have a past history of a bladder tumor Patients with urethral stricture or bladder neck stenosis Patients with a history of surgery causing damage to the pelvic plexus Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder

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: 1. Tamsulosin alone<br> | Drug: Tamsulosin hydrochloride<br>* oral<br>* Other names: YM617;|
| Experimental: 2. Tamsulosin + solifenacin (low dose)<br> | Drug: Tamsulosin hydrochloride<br>* oral<br>* Other names: YM617;Drug: Solifenacin succinate<br>* oral<br>* Other names: YM905;|
| Active Comparator: 3. Tamsulosin + solifenacin (high dose)<br> | Drug: Tamsulosin hydrochloride<br>* oral<br>* Other names: YM617;Drug: Solifenacin succinate<br>* oral<br>* Other names: YM905;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of urgency episodes per 24 hours |  | at 4, 8, 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of micturitions per 24 hrs |  | at 4, 8, 12 week | 
| Mean number of incontinence episodes per 24 hours |  | at 4, 8, 12 week | 
| Mean number of micturitions per night |  | at 4, 8, 12 week | 
| Adverse Events, Laboratory Tests |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Vesicare, Solifenacin succinate, Tamsulosin, Overactive Bladder