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

Last updated: March 27, 2023
Sponsor: Far Eastern Memorial Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Interstitial Cystitis

Treatment

N/A

Clinical Study ID

NCT03251300
106001-F
  • Ages > 20
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Allergy to mirabegron, urinary tract infections, unstable hypertension

Study Design

Total Participants: 120
Study Start date:
August 01, 2017
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Far Eastern Memorial Hospital

    Banqiao, New Taipei 22050
    Taiwan

    Active - Recruiting

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