MIrabegron With oveRACtive bLadder Symptoms in mEn

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Comparison Clinical Study to Investigate the Efficacy and Safety of the β3 Adrenoceptor Agonist, Mirabegron With Overactive Bladder Symptoms in Men

The proportion of male patients who participated in the phase III study of mirabegron was about 28% and the data on the efficacy and safety of mirabegron in Korean male OAB patients have limits. For this reason, this study will assess the efficacy and safety of mirabegron in Korean male OAB patients.

Study Overview

• Status: Unknown
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: placebo; Drug: mirabegron

Detailed Description

About 50 to 75% of men with LUTS secondary to BPH also have overactive bladder symptoms. As a major drug for the treatment of overactive bladder symptoms, muscarinic receptor antagonists are used, but precautions should be taken by a specialist when using muscarinic receptor antagonists due to possibilities of dry mouth, constipation, blurred vision and post-dose dysuria and acute ischuria. Mirabegron is a selective β3-adrenoceptor agonist that relax the detrusor smooth muscle and increase functional bladder capacity to improve overactive bladder symptoms. This study will examine the efficacy and safety of mirabegron, a new drug, for improvement of urinary frequency.

The efficacy of mirabegron compared to the placebo has been demonstrated by the phase III study, but the analysis of only patients in Korea has not obtained significant difference from the placebo. The prevalence of overactive bladder was 9.7% in men and 11.6% in women, which showed similar rates 1), but the cure rate is higher in men than in women (OR 1.891, CI 1.362, 2.2627, p=0.0001). Male patients are important customers for the OAB market and low-dose anticholinergic agents with relatively low risk of urinary retention are preferred for the treatment of male overactive bladder (OAB) in Korea. We will conduct this clinical study because we think mirabegron will be an alternative for the therapy for male OAB patients with a risk of urinary retention.

• Study Type: Interventional
• Enrollment (Anticipated): 462
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Recruiting
    • Korea University Ansan Hospital
    • Contact: Jae Hyun Bae, MD
    • Principal Investigator: Jae Hyun Bae, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Dong Gil Shin, Ph.D.; Phone Number: 82-51-240-7351; Email: shindong16@hanmail.net
    • Principal Investigator: Dong Gil Shin, Ph.D.
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyung kook University Hospital
    • Contact: Eun Sang Yoo, MD; Email: uroyoo@knu.ac.kr
    • Principal Investigator: Eun Sang Yoo, MD
  • Daejeon, Korea, Republic of
    • Recruiting
    • Eulji University Hospital
    • Contact: Seung Hyo Woo, MD, PH D; Email: woosing@eulji.ac.kr
    • Principal Investigator: Seung Hyo Woo, MD, PH D
  • Incheon, Korea, Republic of
    • Recruiting
    • Ga-cheon University Gil Hospital
    • Contact: Sang jin yoon, MD
    • Principal Investigator: Sang jin yoon, MD
  • Kwangju, Korea, Republic of
    • Recruiting
    • Cheonnam University Hospital
    • Contact: Tae Wook Kang, MD, PH D; Email: sydad@hanmail.net
    • Principal Investigator: Tae Wook Kang, MD, PH D
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Soo Woong Kim, M.D., Ph.D.; Phone Number: +82-2-2072-2426; Email: swkim@snu.ac.kr
    • Principal Investigator: Soo Woong Kim, M.D.,Ph.D.
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: In Gab Jeong, MD, PhD; Email: igjeong@amc.seoul.kr
    • Principal Investigator: In Gab Jeong, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Kang Su Cho, MD; Email: kscho99@yuhs.ac
    • Principal Investigator: Kang Su Cho, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Boramae Medical Center
    • Contact: Hwan Cheol Son, MD
    • Principal Investigator: Hwan Cheol Son, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
    • Contact: Young-Goo Lee, MD; Email: uroyglee@nate.com
    • Principal Investigator: Young-Goo Lee, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kang book Samsung Hospital
    • Contact: Kwan joong Joo, MD, PhD; Email: urojoo@dreamwiz.com
    • Principal Investigator: Kwan joong Joo, MD, PhD
  • Gyeonggi
    • Bucheon, Gyeonggi, Korea, Republic of
      • Recruiting
      • Soon Chun Hyang University Hospital Bucheon
      • Contact: Young-Ho Kim; Phone Number: 82-10-2975-3262; Email: yhkuro@schmc.ac.kr
      • Principal Investigator: Young-Ho Kim, Ph.D.
    • Seongnam, Gyeonggi, Korea, Republic of
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Seong-Jin Jeong, MD; Email: urojsj@snubh.org
      • Principal Investigator: Seong-Jin Jeong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male aged 20 years
• Patients with an average of at least 8 micturitions per 24 hours in last 3 days based on the micturition diary
• Patients with an average of at least 1 episode of urgency per 24 hours in last 3 days based on the micturition diary
• Patients who have symptoms of OAB for at least 12 weeks prior to the enrollment
• Patients who are able to complete the micturition diary and questionnaires correctly
• Patients who provided a singed consent form after being informed of the nature of the study and risk and benefit of the study treatment.

Exclusion Criteria:

• Patients with AUR history
• Patients with PSA ≥ 10 ng/ml or suspected prostate cancer
• Patients who have an average total daily urine volume ≥ 3000 mL
• Patients with suspected stress incontinence
• Patients with PVR ≥200 ml or Qmax ≤5ml/sec

• Patients who have used according to the criteria below:

  • Patients who began or discontinued the drug(s) or changed the dose within 4 weeks before enrollment
  • Patients who were treated with an anticholinergic agent, 5-aplha reductase inhibitor within 4 weeks before enrollment
  • Patients who began or discontinued 5ARI treatment or changed the dose within 6 months
• Patients began or has changed a bladder training program or pelvic floor exercises less than 4 weeks prior to Screening.
• Patients who had an indwelling catheter or practices intermittent self-catheterization
• Patients who received surgical treatment that may influence urinary track function (TURP, laser therapy, etc.) within 24 weeks of run-in period
• Uncontrolled hypertension: SBP ≥180 mmHg, DBP ≥110 mmHg
• Pulse rate ≥110 bmp or <50 bpm
• Patients with complications of urinary tract infection, urolithiasis and interstitial cystitis or past history of recurrent urinary tract infection
• Patients with hypersensitivity to β-adrenergic receptor agonists or anticholinergics
• Patients has a clinically significant ECG abnormality, as determined by the Investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; mirabegron placebo qd	Drug: placebo
Experimental: mirabegron; mirabegron 50mg qd	Drug: mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in mean number of micturitions per 24 hours	after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in mean number of urgency episodes per 24 hours	after 12 weeks of treatment
Change in mean number of urgency incontinence episodes per 24 hours	after 12 weeks of treatment
Change in a total of OABSS	after 12 weeks of treatment
Change in residual volume and maximal urinary flow rate	after 12 weeks of treatment
Change in IPSS storage subscore	after 12 weeks of treatment
Change in IPSS-QOL symptom score	after 12 weeks of treatment
Number of Adverse Events of study drug	after 12 and 24 weeks of treatment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Mirabegron
• Other Study ID Numbers: MIRACLE