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

St. Joseph's Healthcare Hamilton

Status and phase: Unknown; Phase 4

Conditions: Benign Prostatic Hyperplasia; Overactive Bladder

Treatments: Drug: Tamsulosin; Drug: Mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT02279615

MIRTAM-2014OB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

(Mirabegron + Tamsulosin)

Treatment:

Drug: Mirabegron

Drug: Tamsulosin

Control Group

Placebo Comparator group

Description:

(Placebo + Tamsulosin)

Treatment:

Drug: Tamsulosin