Urinary Bladder, Overactive
Conditions
Keywords
autonomic nerve system, nocturia, psychologic distress, sexual function, bladder blood perfusion, heart rate variability, overactive bladder syndrome
Brief summary
The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions: Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?
Detailed description
We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks. The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.
Interventions
DRUGMirabegron 25mg
Taking 25 mg mirabegron in the nighttime
DRUGSolifenacin 5 mg
Taking 5 mg solifenacin in the nighttime
DRUGTolterodine 4 mg
Taking 5 mg tolterodine in the nighttime
DRUGOxybutynin ER 5 mg
Taking 5 mg oxybutynin ER in the nighttime
Sponsors
Far Eastern Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old. * female patients with overactive bladder syndrome
Exclusion criteria
* Clinically significant dysuria (inability to urinate, difficulty urinating). * Severe stress urinary incontinence (urinary incontinence caused by coughing). * Mixed urinary incontinence mainly caused by stress urinary incontinence (urinary incontinence caused by coughing as the main symptom). * Contraindications to antimuscarinic drugs or adrenergic receptor agonists.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of overactive bladder symptoms | 12 weeks | Comparisons of the changes of overactive bladder symptom score between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of heart rate variability | 12 weeks | Comparisons of the changes of heart rate variability between groups |
| Change of bladder blood perfusion | 12 weeks | Comparisons of the changes of bladder blood perfusion between groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of quality of life | 12 weeks | Comparisons of the change of King's Health Questionnaire score between groups |
Countries
Taiwan
Outcome results
None listed