Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Far Eastern Memorial Hospital

Status and phase: Enrolling; Phase 3

Conditions: Overactive Bladder Syndrome

Treatments: Drug: Mirabegron; Drug: Solifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT04023253

108003-F

Details and patient eligibility

About

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.

Full description

To assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overactive bladder syndrome

Exclusion criteria

• Allergy to mirabegron or solifenacin.
• Patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of CYP3A4 such as ketoconazole.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

mirabegron

Experimental group

Description:

Receive mirabegron 2 mg treatment per day

Treatment:

Drug: Mirabegron

solifenacin

Experimental group

Description:

Receive solifenacin 5 mg treatment per day

Treatment:

Drug: Solifenacin