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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02279615
Recruitment Status : Unknown
Verified April 2018 by Anil Kapoor, St. Joseph's Healthcare Hamilton.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2014
Last Update Posted : April 3, 2018
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Benign Prostatic Hyperplasia Drug: Mirabegron Drug: Tamsulosin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Treatment Group
(Mirabegron + Tamsulosin)
Drug: Mirabegron
50mg of mirabegron per day will be given.
Other Name: Myrbetriq

Drug: Tamsulosin
0.4mg of flomax per day.
Other Name: Flomax

Placebo Comparator: Control Group
(Placebo + Tamsulosin)
Drug: Tamsulosin
0.4mg of flomax per day.
Other Name: Flomax

Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: Treatment period: 4 weeks ]
    Measured before and after combination therapy.

  2. Quality of Life Score (QoLS) [ Time Frame: Treatment period: 4 weeks ]
    Measured before and after combination therapy

  3. Overactive Bladder Symptom Score (OABSS) [ Time Frame: Treatment period: 4 weeks ]
    Measured before and after combination therapy

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Timeline: 4 weeks ]
    Measured during treatment of combination therapy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02279615

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Contact: Taehyoung Lee, MD, PGY4 905-522-1155 ext 36188
Contact: Camilla Tajzler, BA, CCRA 905-522-1155 ext 35876

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Canada, Ontario
St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
Hamilton, Ontario, Canada, L8N4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
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Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University
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Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton Identifier: NCT02279615    
Other Study ID Numbers: MIRTAM-2014OB
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anil Kapoor, St. Joseph's Healthcare Hamilton:
Overactive Bladder
Benign Prostatic Hyperplasia
Combination Therapy
β3-Adrenoceptor Agonist
α-Adrenoceptor Antagonist
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Prostatic Hyperplasia
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Prostatic Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists