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

NCT07114640 — Phase 3, Not yet recruiting, 220 participants, Far Eastern Memorial Hospital

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Far Eastern Memorial Hospital

Registry	NCT07114640
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	220 (Estimated)
Sponsor	Far Eastern Memorial Hospital (Other)
Conditions	Urinary Bladder, Overactive
Interventions	Mirabegron 25mg, Solifenacin 5 mg, Tolterodine 4 mg, Oxybutynin ER 5 mg (Drug)
Dates	start 2025-08-07 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2025-08-11, last updated 2025-08-11
Locations	1 site in Taiwan

-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?

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
mirabegron	Active comparator	Drug: Mirabegron 25mg	mirabegron 25 mg
Solifenacin	Active comparator	Drug: Solifenacin 5 mg	Solifenacin 5mg
Tolterodine	Active comparator	Drug: Tolterodine 4 mg	Tolterodine 4mg
Oxybutynin ER	Active comparator	Drug: Oxybutynin ER 5 mg	Oxybutynin ER 5mg

Mirabegron 25mg (Drug): Taking 25 mg mirabegron in the nighttime
Solifenacin 5 mg (Drug): Taking 5 mg solifenacin in the nighttime
Tolterodine 4 mg (Drug): Taking 5 mg tolterodine in the nighttime
Oxybutynin ER 5 mg (Drug): Taking 5 mg oxybutynin ER in the nighttime

+Outcome measures

Primary outcomes

Improvement of overactive bladder symptoms [12 weeks]: Comparisons of the changes of overactive bladder symptom score between groups

Secondary outcomes

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 outcomes

Change of quality of life [12 weeks]: Comparisons of the change of King's Health Questionnaire score between groups

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,	Banqiao District, New Taipei	Taiwan