NCT04023253

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

5.4 years

First QC Date

July 12, 2019

Last Update Submit

September 14, 2023

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • Global response assessment

    Between-group difference in the score of Global response assessment

    12 weeks

Secondary Outcomes (4)

  • Total score of Brief Symptoms Rating Scales

    12 weeks

  • Female sexual function index

    12 weeks

  • Bladder wall thickness

    12 weeks

  • Blood flow index of the bladder

    12 weeks

Study Arms (2)

mirabegron

EXPERIMENTAL

Receive mirabegron 2 mg treatment per day

Drug: Mirabegron

solifenacin

EXPERIMENTAL

Receive solifenacin 5 mg treatment per day

Drug: Solifenacin

Interventions

MirabegronDRUG

Mirabegron 25 mg

mirabegron
SolifenacinDRUG

Solifenacin 5 mg

solifenacin

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overactive bladder syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Interventions

mirabegronSolifenacin Succinate

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886289667000smhsiao2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief and Associate Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 17, 2019

Study Start

August 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)