Overactive bladder
Conditions
Interventions
For patients who are insufficient with mirabegron 50mg once a day for more than 8 weeks, 5mg of solifenacin will be orally administered once a day after breakfast for 12 weeks.
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female 2) OAB patients who are treated with 50 mg OD of mirabegron for more than 8 weeks before registration. 3) OAB patients (OABSS >=3, urgency score (OABSS) >= 2 and QOL score >=4) in 2 points within 4 weeks before registration and on registration. 4) Patients with hope of drug change 5) Patients from whom we have received written consent.
Exclusion criteria
Exclusion criteria: 1) Patients with taking drugs that have an influence on the urination function. 2) Patients that the malignancy of the lower urinary tract is doubted. 3) Patients that detrusor muscular low activity is doubted. 4) Patients with urethral stricture. 5) Patients that carried out radiotherapy to pelvic part. 6) Patients with active urine tract infection. 7) Patients with urinary tract calculus, interstitial cystitis. 8) Patients with the practice of intermittent self-catheterization. 9) Patients with serious liver dysfunction, kidney dysfunction and heart disease. 10) Patients with polyuria. 11) Contraindicated case of anti-cholinergic agents (solifenacin). *patients with obstruction of pylorus, duodenum and intestinal tract. *patients with closure-angle glaucoma. *patient with gastric atony or intestinal atony. *patients with myasthenia gravis. 12) Patients with neurogenic bladder. 13) Residual urine volume is more than 100mL. 14) Patients that take solifenacin and other anti-cholinergic agents within 6 months before mirabegron administration. 15) Any other patients that are regarded as unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of total OABSS score from registration to last observation (12weeks later or discontinuation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change of QOL score from registration to last observation (12weeks later or discontinuation) 2) Change of contents in frequent volume chart from registration to last observation (12weeks later or discontinuation) 3) Change of residual urine volume from registration to last observation (12weeks later or discontinuation) 4) Adverse events (item and incidence) | — |
Countries
Japan
Contacts
Public ContactNarihito Seki
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers Department of Urology
Outcome results
None listed