NCT04550702

Brief Summary

Recurrence of female overactive bladder syndrome (OAB) is not uncommon. It is important to decrease the recurrence of female OAB. However, factors predicting recurrence of female OAB, especially for those women who need retreatment is undetermined. Thus, the aim of this study was to elucidate factors predicting retreatment of female OAB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

July 1, 2020

Enrollment Period

4.6 years

First QC Date

September 9, 2020

Last Update Submit

September 9, 2020

Conditions

Keywords

overactive bladder syndromebeta-3 agonistretreatment

Outcome Measures

Primary Outcomes (1)

  • Recurrent OAB

    Recurrent OAB with needs to retreatment

    January 2015 to July 2019

Study Arms (1)

Women received Mirabegron

Women with overactive bladder syndrome received Mirabegron

Drug: Mirabegron 25mg

Interventions

Mirabegron 25 mg per day

Also known as: Betmiga
Women received Mirabegron

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with overactive bladder syndrome who completed urodynamic study and bladder diary and received Mirabegron 25 mg per day

You may qualify if:

  • Women with overactive bladder syndrome
  • Women complete urodynamic study and bladder diary

You may not qualify if:

  • Pregnant women
  • Incomplete data
  • Loss of follow-up
  • Acute or chronic urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

  • Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.

  • Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15.

  • Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20.

  • Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3.

  • Hsiao SM, Chang TC, Chen CH, Wu WY, Lin HH. Frequent nocturia episodes, a suboptimal response to treatment, and small bladder capacity predict the need for persistent antimuscarinic therapy or re-treatment after discontinuation of antimuscarinics in female overactive bladder. Menopause. 2017 Jan;24(1):100-104. doi: 10.1097/GME.0000000000000730.

MeSH Terms

Interventions

mirabegron

Study Officials

  • Ho-Hsiung Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

January 1, 2015

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

IPD will be shared under reasonable request

Locations