Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and efficacy of combination therapy involving β3-adrenoceptor agonist, mirabegron, and α-blockers for the treatment of OAB symptoms in male patients with BPH.

Detailed Description
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Mirabegron (MyrbetriqTM, Astellas Pharma Inc.) is a drug that is approved by the FDA for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency and urgency incontinence. Multiple studies have shown that this drug also has the potential to improve patient tolerability, compliance and subsequent patient quality of life without inducing unfavourable adverse events commonly associated with antimuscarinic medications. These adverse events include, but are not limited to, dry mouth, constipation, confusion, and acute urinary retention (AUR). Studies now have shown that mirabegron may also provide an effective treatment option for OAB in men with benign prostatic hyperplasia (BPH) without inducing the above mentioned adverse events. This study will look at the combination therapy of Mirabegron and Tamsulosin, versus Tamsulosin and placebo alone to prove that this treatment (Mirabegron and Tamsulosin) is effective for those men who suffer from both overactive bladder along with benign prostatic hyperplasia.

Official Title
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EFFICACY AND SAFETY OF COMBINATION THERAPY WITH β3-ADRENOCEPTOR AGONIST (MIRABEGRON) AND α-ADRENOCEPTOR ANTAGONIST (TAMSULOSIN) FOR TREATMENT OF OVERACTIVE BLADDER IN MALE PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA.

Conditions
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Overactive Bladder, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Mirabegron
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients over the age of 50 Clinical BPH on stable dose of alpha-blocker therapy for more than 1 month OAB symptoms (frequency, urgency, nocturia, urgency incontinence) Exclusion Criteria: Post-void residual (PVR) > 200mL Active, culture-proven urinary tract infection Acute/chronic prostatitis Previous lower urinary tract malignancy (i.e. bladder, prostate malignancy) History of cystolithiasis Previous pelvic surgery (i.e. prostatectomy, cystectomy, recent pelvic/endourologic instrumentation including cystoscopy, nephroscopy, ureteral stent insertion, Transrectal Ultrasound (TRUS) biopsy) Previous pelvic radiation

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>(Mirabegron + Tamsulosin) | Drug: Mirabegron<br>* 50mg of mirabegron per day will be given.<br>* Other names: Myrbetriq;Drug: Tamsulosin<br>* 0.4mg of flomax per day.<br>* Other names: Flomax;|
| Placebo Comparator: Control Group<br>(Placebo + Tamsulosin) | Drug: Tamsulosin<br>* 0.4mg of flomax per day.<br>* Other names: Flomax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | Measured before and after combination therapy. | Treatment period: 4 weeks | 
| Quality of Life Score (QoLS) | Measured before and after combination therapy | Treatment period: 4 weeks | 
| Overactive Bladder Symptom Score (OABSS) | Measured before and after combination therapy | Treatment period: 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Measured during treatment of combination therapy. | Timeline: 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Benign Prostatic Hyperplasia, Combination Therapy, β3-Adrenoceptor Agonist, Mirabegron, Myrbetriq, α-Adrenoceptor Antagonist, Tamsulosin, Flomax