Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

NCT ID: NCT04023253

Last Updated: 2023-09-15

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mirabegron

Receive mirabegron 2 mg treatment per day

Group Type EXPERIMENTAL

Mirabegron

Intervention Type DRUG

Mirabegron 25 mg

solifenacin

Receive solifenacin 5 mg treatment per day

Group Type EXPERIMENTAL

Solifenacin

Intervention Type DRUG

Solifenacin 5 mg

Interventions

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Mirabegron

Mirabegron 25 mg

Intervention Type DRUG

Solifenacin

Solifenacin 5 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief and Associate Professor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sheng-Mou Hsiao, MD

Role: CONTACT

+886289667000 ext. 1818

Facility Contacts

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Sheng-Mou Hsiao, M.D.

Role: primary

+886-2-89667000 ext. 1818

Other Identifiers

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108003-F

Identifier Type: -

Identifier Source: org_study_id

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