Investigation on efficacy and safety of combination treatment with imidafenacin and mirabegron in patients with overactive bladder.

Not Applicable

• Conditions: overactive bladder

• Registration Number: JPRN-UMIN000016236
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Start of observation period (-4wks) 1) Patients who has contraindication of imidafenacin 1. Patients with urinary retention. 2. Patients with pyloric stenosis, duodenal ileus, enterocleisis and patients with adynamic ileus. 3. Patients with deterioration of enterokinesis. 4. Patients with narrow-angle glaucoma. 5. Patients with myasthenia gravis. 6. Patients with serious cardiac disorder. 7. Patients with a history of hypersensitivity to imidafenacin. 2) Patients who has contraindication of mirabegron. 1. Patients with a history of hypersensitivity to mirabegron. 2. Patients with serious cardiac disorder. 3. Women who have pregnancy, possibility of the pregnancy. 4. Women who are nursing. 5. Patients with serious liver dysfunction (Child-Pugh score >=10). 6. Patients taking flecainide acetate or propafenone hydrochloride. 3) Patients with severe difficulty of urination. 4) Patients with history of urinary retention 5) Patients with arrhythmia. 6) Patients with hypokalemia. 7) Patients with serious kidney dysfunction. 8) Patients with bladder cancer, prostate cancer, stones in bladder, urinary tract stones, interstitial cystitis, prostatitis and symptomatic urinary tract infection. 9) Patients with genuine stress urinary incontinence. 10) Patients with polyuria. 11) Patients with severe hypertension (SBP >=180mmHg and/or DBP >=110mmHg under sitting position). 12) Patients who have administered prohibited substances or done prohibited therapy within 4 weeks before observation period. 13) Patients who have a urology or genital surgery within the 6 months before observation period. 14) Patients with unstable lower urinary tract symptoms. 15) Patients taking drugs that have possibility of QT prolongation. 16) Any other patients who are regarded as unsuitable for this study by the investigator Treatment period (at 0 week): 1)Residual urine volume is more than 50 mL 2)Patients with QT interval >450ms or risk of QT prolongation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reaction. 1) Incidence of QT prolongation (ECG findings: change of QT interval) 2) Incidence of other adverse drug reactions.

Secondary Outcome Measures

Name	Time	Method
1) Baseline change of IPSS (International prostate symptom score) Q7 from 0week to 12 weeks. 2) Change of total OABSS (overactive bladder symptom score) and OABSS sub-score (diurnal frequency, nocturia, urinary urgency and impending incontinence). 3) Change of total IPSS score and IPSS sub-score (urination symptom, storage symptom). 4) Change of urination diary contents (the number of day urination, the number of night urination, the number of urinary urgency, the number of impending incontinence, dairy urination volume, night urination volume) 5) Change of first awakening time. 6) Change of residual urine volume. 7) Change of blood pressure and pulse.