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Predictors for Retreatement of OAB After DC Mirabegron

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ClinicalTrials.gov Identifier: NCT04550702
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment
Recurrence of Overactive Bladder Syndrome Drug: Mirabegron 25mg

Detailed Description:
The medical records, including pad testing, urodynamic studies, lower urinary tract symptoms related questionnaires and bladder diaries of all consecutive women with OAB, who visited urogynecologic clinics in a tertiary referral center, were reviewed. Persistence interval was defined from the date of prescription of mirabegron to the date of discontinuation of mirabegron treatment. Statistical analysis was performed with Kaplan-Meier estimator. Multivariable Cox proportional-hazard model with all variables with p < 0.25 in the univariate analysis was performed to predict OAB retreatment probability.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictor for Re-treatment of Overactive Bladder Syndrome After Discontinuation of Mirabegron Treatment for Female Overactive Bladder Syndrome
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Group/Cohort Intervention/treatment
Women received Mirabegron
Women with overactive bladder syndrome received Mirabegron
Drug: Mirabegron 25mg
Mirabegron 25 mg per day
Other Name: Betmiga




Primary Outcome Measures :
  1. Recurrent OAB [ Time Frame: January 2015 to July 2019 ]
    Recurrent OAB with needs to retreatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with overactive bladder syndrome who completed urodynamic study and bladder diary and received Mirabegron 25 mg per day
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550702


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital
Publications of Results:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04550702    
Other Study ID Numbers: 202006091RIND
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared under reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
overactive bladder syndrome
beta-3 agonist
retreatment
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Recurrence
Disease
Pathologic Processes
Disease Attributes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents