Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Phase 3

Recruiting

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: Mirabegron; Drug: Solifenacin

• Registration Number: NCT04023253
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Study Start: 2019-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mirabegron	Mirabegron	Receive mirabegron 2 mg treatment per day
solifenacin	Solifenacin	Receive solifenacin 5 mg treatment per day

Primary Outcome Measures

Name	Time	Method
Global response assessment	12 weeks	Between-group difference in the score of Global response assessment

Secondary Outcome Measures

Name	Time	Method
Female sexual function index	12 weeks	Between-group difference in the changes of total score of female sexual function index
Total score of Brief Symptoms Rating Scales	12 weeks	Between-group difference in the changes of total score of Brief Symptoms Rating Scales
Bladder wall thickness	12 weeks	Between-group difference in the changes of bladder wall thickness
Blood flow index of the bladder	12 weeks	Between-group difference in the changes of blood flow index of the bladder

Trial Locations

Locations (1)

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