Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing

Overactive Bladder Syndrome Clinical Trial

Official title:

Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251300
• Other study ID #: 106001-F
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Far Eastern Memorial Hospital
• Contact: Sheng-Mou Hsiao, MD
• Phone: +886289667000
• Email: smhsiao2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.

Patients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses.

Possible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• OAB symptoms for at least one month

• >20 years

Exclusion Criteria:

• Allergy to mirabegron, urinary tract infections, unstable hypertension

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturia episodes	comparison of baseline and post-treatment nocturia episodes from bladder diary	12 weeks
Secondary	Severity of nocturia	comparison of baseline and post-treatment severity of nocturia from questionnaires	12 weeks