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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

NCT04023253

Overactive Bladder Syndrome

UNKNOWN PHASE3

Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing

NCT03251300

Overactive Bladder Syndrome

UNKNOWN PHASE4

Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

NCT05040984

Overactive Bladder Syndrome

UNKNOWN

Comparisons of the Impact of Monotherapy With Mirabegron or Tolterodine Versus Combined Treatment With Mirabegron and Tolterodine on Autonomic Function and Bladder Blow Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study

NCT05946902

Female Patients With Overactive Bladder Syndrome

UNKNOWN PHASE4

Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes

NCT02540707

Overactive Bladder Syndrome

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Bladder, Overactive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mirabegron

mirabegron 25 mg

Group Type ACTIVE_COMPARATOR

Mirabegron 25mg

Intervention Type DRUG

Taking 25 mg mirabegron in the nighttime

Solifenacin

Solifenacin 5mg

Group Type ACTIVE_COMPARATOR

Solifenacin 5 mg

Intervention Type DRUG

Taking 5 mg solifenacin in the nighttime

Tolterodine

Tolterodine 4mg

Group Type ACTIVE_COMPARATOR

Tolterodine 4 mg

Intervention Type DRUG

Taking 5 mg tolterodine in the nighttime

Oxybutynin ER

Oxybutynin ER 5mg

Group Type ACTIVE_COMPARATOR

Oxybutynin ER 5 mg

Intervention Type DRUG

Taking 5 mg oxybutynin ER in the nighttime

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirabegron 25mg

Taking 25 mg mirabegron in the nighttime

Intervention Type DRUG

Solifenacin 5 mg

Taking 5 mg solifenacin in the nighttime

Intervention Type DRUG

Tolterodine 4 mg

Taking 5 mg tolterodine in the nighttime

Intervention Type DRUG

Oxybutynin ER 5 mg

Taking 5 mg oxybutynin ER in the nighttime

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No