Clinical trial NCT02279615: Efficacy And Safety Of Combination Therapy For Treatment Of Overactive Bladder In Male Patients With Benign Prostatic Hyperplasia.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder
Benign Prostatic Hyperplasia
Keywords: Overactive Bladder
Benign Prostatic Hyperplasia
Combination Therapy
β3-Adrenoceptor Agonist
Mirabegron
Myrbetriq
α-Adrenoceptor Antagonist
Tamsulosin
Flomax
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 200
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Treatment period: 4 weeks
measure: Quality of Life Score (QoLS)
timeFrame: Treatment period: 4 weeks
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: Treatment period: 4 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: Timeline: 4 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
state: Ontario
Study officials:
affiliation: McMaster University
name: Anil Kapoor, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: