MIrabegron With oveRACtive bLadder Symptoms in mEn

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Mirabegron

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