The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirabegron 25mg, Solifenacin 5 mg, Tolterodine 4 mg, Oxybutynin ER 5 mg.
- Who it may be relevant to
- Registry conditions: Urinary Bladder, Overactive. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Far Eastern Memorial Hospital
Overview
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
- Drug Mirabegron 25mg
Taking 25 mg mirabegron in the nighttime - Drug Solifenacin 5 mg
Taking 5 mg solifenacin in the nighttime - Drug Tolterodine 4 mg
Taking 5 mg tolterodine in the nighttime - Drug Oxybutynin ER 5 mg
Taking 5 mg oxybutynin ER in the nighttime
Primary outcome measures
- Improvement of overactive bladder symptoms [Time frame: 12 weeks]
Secondary outcome measures (2)
- Change of heart rate variability [Time frame: 12 weeks]
- Change of bladder blood perfusion [Time frame: 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, — Banqiao District
Identifiers
NCT: NCT07114640 · 110416-F