Mirabegron,beta-3 adrenoceptor agonist, Evaluate on efficacy, tolerability and QOL,in female overactive bladder with nocturia

Not Applicable

• Conditions: Overactive bladder

• Registration Number: JPRN-UMIN000012804
• Lead Sponsor: -QOL Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-10
• Study Completion: 2015-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients with a history of hypersensitivity to mirabegron (2)Patients with a severe heart disease [Mirabegron might worsen the heart disease since some adverse reactions such as heart rate elevation by mirabegron have been reported] (3)Patients on medication with anti-arrhythmics, such as flecainide acetate or propafenone hydrochloride (4)Patients with long QT syndrome (5)Patients prone to occur arrhythmia such as severe bradycardia or acute myocardial ischemia (6)Patients who were taking anticholinergic drugs to treat OAB less than 3 months before study participation (7)Patients with hypokalemia (8)Patients with difficult-to-control hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg, in a seated position) (9)Patients with severe liver dysfunction (10)Patients with renal failure (11)Patients with glaucoma (12)Patients with urination difficulty (13)Patients with anuresis (14)Patients whose residual urinary volume during the observational period is more than 100 mL (15)Patients under treatment with placement of catheter or intermittent self-catheterization (16)Patients whose urinary volume is more than 40mL/kg a day on average (17)Patients complicated with urinary infection, urinary lithiasis or interstitial cystitis (18)Patients complicated with bladder tumor (19)Patients undergone surgical operation that might affect their urinary function within 6 months prior to study participation (20)Patients who received non-drug therapy such as electrical stimulation (low-frequency therapy and magnetic stimulation, for example), biofeedback procedure, bladder training or pelvic floor muscle exercise within 6 months prior to initiation of the observational period (21)Patients complied with/or with a history of mood disorder, psychoneurotic disorder or schizophrenia (22)Patients considered as ineligible for this study by the investigator for other reasons

Study & Design

• Study Type: Observational
• Study Design: Not specified