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

Far Eastern Memorial Hospital

Status and phase: Enrolling; Phase 4

Conditions: Female Patients With Overactive Bladder Syndrome

Treatments: Drug: mirabegron; Drug: tolterodine; Drug: tolterodine , mirabegron

Study type: Interventional

Funder types: Other

Identifiers

NCT05946902

112019-F

Details and patient eligibility

About

To evaluate the impact of combined therapy on the heart rate variability, compared with monotherapy in women with overactive bladder syndrome. Secondary objective is to evaluate the impact of combined therapy on bladder blood perfusion.

Full description

Patients and methods:

We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital, and will recruit 150 female patients with overactive bladder syndrome. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the urgency severity score, the overactive bladder symptom score questionnaire, and the King's health questionnaire before taking the drug and four weeks and twelve weeks after taking the drug. In addition, measurement of heart rate variability and bladder blood perfusion will be performed.

Expected results:

We will obtain the impact of monotherapy with tolterodine or mirabegron versus combined therapy on heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >20 years old .
• female patients with overactive bladder syndrome

Exclusion criteria

• Cases of hypersensitivity to mirabegron or tolterodine.
• Betanley is contraindicated in the following patients: uncontrolled severe hypertension.
• Dexotol is contraindicated in the following patients: known urethral diverticulum, known bladder malignancy, patients with urinary retention and gastric retention, patients with uncontrolled narrow-angle glaucoma, patients with renal dialysis, severe renal dysfunction (ie Inulin clearance rate (GFR<30 ml/min) or liver dysfunction (i.e. liver cirrhosis), use strong CYP3A4 inhibitors such as ketoconazole.
• Patients with myasthenia gravis.
• The patient is taking drugs that interact with tolterodine or mirabegron.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

mirabegron

Active Comparator group

Description:

mirabegron 25 mg

Treatment:

Drug: mirabegron

tolterodine

Active Comparator group

Description:

tolterodine 4 mg

Treatment:

Drug: tolterodine

combined therapy

Experimental group

Description:

tolterodine 4 mg \& mirabegron 25 mg

Treatment:

Drug: tolterodine , mirabegron