MIrabegron With oveRACtive bLadder Symptoms in mEn

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Feb 6, 2015

Keywords

ClinConnect Summary

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 effica...

Gender

MALE

Eligibility criteria

• 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