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

Far Eastern Memorial Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: Tolterodine 4 mg; Drug: Oxybutynin ER 5 mg; Drug: Solifenacin 5 mg; Drug: Mirabegron 25mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07114640

110416-F

Details and patient eligibility

About

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?

Full 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.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

mirabegron

Active Comparator group

Description:

mirabegron 25 mg

Treatment:

Drug: Mirabegron 25mg

Solifenacin

Active Comparator group

Description:

Solifenacin 5mg

Treatment:

Drug: Solifenacin 5 mg

Tolterodine

Active Comparator group

Description:

Tolterodine 4mg

Treatment:

Drug: Tolterodine 4 mg

Oxybutynin ER

Active Comparator group

Description:

Oxybutynin ER 5mg

Treatment:

Drug: Oxybutynin ER 5 mg