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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Mirabegron; Drug: Tamsulosin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Taehyoung Lee, MD, PGY4; Phone Number: 36188 905-522-1155; Email: taehyoung.lee@medportal.ca
• Study Contact Backup: Name: Camilla Tajzler, BA, CCRA; Phone Number: 35876 905-522-1155; Email: tajzlec@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St. Joseph's Healthcare Hamilton - McMaster Institute of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Overactive Bladder; Combination Therapy; Mirabegron; Tamsulosin; Myrbetriq; Flomax; β3-Adrenoceptor Agonist; α-Adrenoceptor Antagonist
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic beta-3 Receptor Agonists; Tamsulosin; Mirabegron
• Other Study ID Numbers: MIRTAM-2014OB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No