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

Not Applicable

Not yet recruiting

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: Mirabegron 25mg; Drug: Solifenacin 5 mg; Drug: Tolterodine 4 mg; Drug: Oxybutynin ER 5 mg

• Registration Number: NCT07114640
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study Start: 2025-08-07
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mirabegron	Mirabegron 25mg	mirabegron 25 mg
Solifenacin	Solifenacin 5 mg	Solifenacin 5mg
Tolterodine	Tolterodine 4 mg	Tolterodine 4mg
Oxybutynin ER	Oxybutynin ER 5 mg	Oxybutynin ER 5mg

Primary Outcome Measures

Name	Time	Method
Improvement of overactive bladder symptoms	12 weeks	Comparisons of the changes of overactive bladder symptom score between groups

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,; 🇨🇳 Banqiao, New Taipei, Taiwan