Clinical trial NCT04693897: Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker
Official title: To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder Syndrome
Detrusor Overactivity
Keywords: Overactive Bladder Syndrome
Mirabegron
Beta3-adrenoceptor agonist
Detrusor Overactivity
Urodynamics
Biomarker
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with overactive bladder syndrome for 3 or more months with or without concurrent detrusor overactivity treated as outpatient.

Brief summary: About one to two million women in Taiwan suffers from overactive bladder (OAB). The most commonly used anti-muscarinic drugs have a high rate of side effects. While beta-3 adrenoceptor agonist, Mirabegron, has far fewer side effects, there are no consensus on whether it can be used as first-line treatment. The investigator's preliminary study showed that the concentration of beta-3 adrenoceptor in the urine of OAB patients is higher than that in the normal control group, so comparing urinary beta-3 adrenoceptor concentration of OAB patients before and after treatment may be used as a biomarker of therapeutic effectiveness. The results of this study will be of great help in understanding the effectiveness of Mirabegron and formulating OAB treatment plans.


Eligibility criteria: Inclusion Criteria:

* Diagnosis compatible with 2002 ICS for overactive bladder syndrome
* Symptoms persisted for more than 3 months
* Completed pre-treatment urodynamic study
* Has plans for treatment with Mirabegron or Solifenacin due to clinical symptoms
* Patient is willing to cooperate with study including follow up and complete questionnaire surveys

Exclusion Criteria:

* Has stress urinary incontinence
* Pelvic organ prolapse
* Interstitial cystitis
* Constipation
* Gastroesophageal reflux disease
* Prior failed medical treatment for overactive bladder syndrome
* Uncontrolled hypertension
* Glaucoma
* Currently pregnant
* Using other medications for overactive bladder syndrome

Primary outcomes:
measure: Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment
timeFrame: 12 weeks
measure: Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.
timeFrame: 6 months
measure: Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment
timeFrame: 6 months
measure: Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
timeFrame: 6 months
measure: The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
timeFrame: 12 weeks
measure: The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
timeFrame: 6 months
measure: Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
timeFrame: 12 weeks
measure: Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.
timeFrame: 6 months
measure: Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
timeFrame: 12 weeks
measure: Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment
timeFrame: 6 months
measure: Effect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.
timeFrame: 12 weeks
measure: Effect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.
timeFrame: 6 months
measure: The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.
timeFrame: 12 weeks
measure: The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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