Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Comparisons of the Impact of Beta-3 Agonist Versus Antimuscarinics on Psychological Distress, Sexual Function, Bladder Wall Thickness and Blood Flow in Women With Overactive Bladder Syndrome: a Randomized Controlled Study.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04023253

Enrollment

120

Registered

2019-07-17

Start date

2019-08-01

Completion date

2024-12-31

Last updated

2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

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.

Interventions

DRUGMirabegron

Mirabegron 25 mg

DRUGSolifenacin

Solifenacin 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Global response assessment	12 weeks	Between-group difference in the score of Global response assessment

Secondary

Measure	Time frame	Description
Total score of Brief Symptoms Rating Scales	12 weeks	Between-group difference in the changes of total score of Brief Symptoms Rating Scales
Female sexual function index	12 weeks	Between-group difference in the changes of total score of female sexual function index
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

Countries

Taiwan

Contacts

Primary ContactSheng-Mou Hsiao, MD

smhsiao2@gmail.com+886289667000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026