NCT03251300

Brief Summary

The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.

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 P50-P75 for phase_4

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_4

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

August 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
7.4 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

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

7.4 years

First QC Date

August 10, 2017

Last Update Submit

March 27, 2023

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

  • Nocturia episodes

    comparison of baseline and post-treatment nocturia episodes from bladder diary

    12 weeks

Secondary Outcomes (1)

  • Severity of nocturia

    12 weeks

Study Arms (2)

group A

EXPERIMENTAL

daytime dosing of mirabegron

Drug: daytime dosing of mirabegron

group B

ACTIVE COMPARATOR

nighttime dosing of mirabegron

Drug: nighttime dosing of mirabegron

Interventions

daytime dosing of mirabegronDRUG

All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron

group A
nighttime dosing of mirabegronDRUG

All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron

group B

Eligibility Criteria

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

You may qualify if:

  • OAB symptoms for at least one month
  • \>20 years

You may not qualify if:

  • Allergy to mirabegron, urinary tract infections, unstable hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

Related Publications (2)

  • Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.

    PMID: 28714288RESULT

  • Hsiao SM. Mirabegron nighttime versus daytime dosing for women with overactive bladder syndrome: a randomized controlled trial. Sci Rep. 2025 Aug 21;15(1):30687. doi: 10.1038/s41598-025-15780-5.

    PMID: 40841399DERIVED

Central Study Contacts

Sheng-Mou Hsiao, MD

CONTACT

+886289667000smhsiao2@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 16, 2017

Study Start

August 1, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

TW(1)