A Phase 3 interventional study of Mirabegron 25mg and Solifenacin 5 mg in Urinary Bladder, Overactive, sponsored by Far Eastern Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Far Eastern Memorial Hospital · Phase 3, Interventional, and Treatment
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?
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 220 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Far Eastern Memorial Hospital is the lead sponsor of 260 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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mirabegron 25 mg
Drug: Mirabegron 25mg
Solifenacin 5mg
Drug: Solifenacin 5 mg
Tolterodine 4mg
Drug: Tolterodine 4 mg
Oxybutynin ER 5mg
Drug: Oxybutynin ER 5 mg
Taking 25 mg mirabegron in the nighttime
Taking 5 mg solifenacin in the nighttime
Taking 5 mg tolterodine in the nighttime
Taking 5 mg oxybutynin ER in the nighttime
Improvement of overactive bladder symptoms
Comparisons of the changes of overactive bladder symptom score between groups
Time frame: 12 weeks
Change of heart rate variability
Comparisons of the changes of heart rate variability between groups
Time frame: 12 weeks
Change of bladder blood perfusion
Comparisons of the changes of bladder blood perfusion between groups
Time frame: 12 weeks
Change of quality of life
Comparisons of the change of King's Health Questionnaire score between groups
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Mirabegron · Solifenacin · Tolterodine · Oxybutynin
Far Eastern Memorial Hospital →