Overactive bladder
Conditions
Interventions
Treatment group receiving daily mirabegron 50mg for 12 weeks
Placebo group
Sponsors
Al Zahraa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for this study were patients with a clinical diagnosis of PD according to UK Brain Bank Criteria which demands bradykinesia and one additional symptom (rigidity, resting tremor, or postural instability). The diagnostic criteria were tested by a movement disorders specialist in the 12 months before receiving mirabegron therapy. Patients should be aged between 40 and 70 years, have a stable dose of antiparkinsonian drugs 8 weeks before study entry, stage 1 to 3 on modified Hoehn and Yahr scale. Patients received mirabegron 50 mg once daily, have post-void residue less than 100ml on an ultrasound of the bladder performed before study entry, patients were taking only levodopa or dopamine agonist at stable doses before entering the study, used at least for 12 weeks mirabegron 50mg and accomplish one visit of followup at the end of therapy.
Exclusion criteria
Exclusion criteria: Exclusion criteria were patients with secondary parkinsonism syndromes, patients with polyuria with a daily urine volume more than 3000 mL, patients receiving monoamine oxidase B inhibitors and catecholOmethyltransferase (COMT) inhibitors for PD, patients operated previously by deep brain stimulation, patients taking anticholinergic medications for (overactive bladder) OAB symptoms, history of benign prostatic hypertrophy (males only), patients with stress urinary incontinence, history of severe uncontrolled hypertensive patients (defined as systolic blood pressure more oe equal than 180 mm Hg and/or diastolic blood pressure more or equal than 110 mm Hg) or bladder outflow obstruction or gastrointestinal obstructive disorders, history of narrow-angle glaucoma, history of pelvic radiation. More exclusion criteria included: current treatment with digoxin, ketoconazole, drugs classified as CYP2D6 substrate, patients with a history of QT interval prolongation or taking drugs that prolong the QT interval, patients with severe renal impairment (GFR less than30ml per min) or moderate to severe hepatic impairment (ChildPugh B&C).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of our study were the change from baseline in OAB symptom score, overactive bladder questionnaire short form score | — |
Countries
Asia(except Japan)
Contacts
Public ContactMohamad Moussa
Al Zahraa Hospital Urology
Outcome results
None listed