NCT05040984

Brief Summary

A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

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

Study Start

First participant enrolled

April 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
3.3 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

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

September 2, 2021

Last Update Submit

March 27, 2023

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • Predictors of persistence of mirabegron versus solifenacin use

    13 years

Study Arms (2)

solifenacin

Drug: Solifenacin Oral Tablet

mirabegron

Drug: Mirabegron 25mg

Interventions

Solifenacin Oral TabletDRUG

Solifenacin 1 tablet per day

solifenacin
Mirabegron 25mgDRUG

Mirabegron 1 tablet per day

mirabegron

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment.

You may qualify if:

  • Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment

You may not qualify if:

  • \<20 year-old

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

Solifenacin Succinatemirabegron

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886919302632smhsiao2@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 10, 2021

Study Start

April 30, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

TW(1)