Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker

January 25, 2021 updated by: Ching-Chung Liang, Chang Gung Memorial Hospital

To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overactive bladder with Mirabegron
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Mirabegron 50mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
Drug: Mirabegron 50 MG
Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome
Overactive bladder with Solifenacin
100 patients with overactive bladder syndrome, diagnosed according to 2002 ICS diagnosis will undergo 12 weeks of Solifenacin 5mg once daily use. Evaluation include questionnaire survey and urine beta-3 adrenoceptor concentration.
Drug: Solifenacin Succinate 5 MG
Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome
Urinary tract infection
Urinary samples for beta-3 adrenoceptor concentration of 100 patients with urinary tract infection.
Control
Urinary samples for beta-3 adrenoceptor concentration of 100 patients without lower urinary tract symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment
Time Frame: 12 weeks
Concentrations of urinary beta-3 adrenoceptor levels will be analyzed for 1)before and after treatment of patients with overactive bladder syndrome treated with Mirabegron; 2)before and after treatment patients with overactive bladder syndrome treated with Solifenacin; 3)patients with urinary tract infection, and 4)control (subjects without lower urinary tract symptoms).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment
Time Frame: 12 weeks
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
12 weeks
Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
6 months
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.
Time Frame: 12 weeks
Individual participant's change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
12 weeks
Change in impact on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment
Time Frame: 6 months
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
6 months
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Time Frame: 12 weeks
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
12 weeks
Effect on the participant's life after treatment with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
6 months
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity after 12 weeks of treatment.
Time Frame: 12 weeks
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron with overactive bladder with or without detrusor overactivity 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron with and without detrusor overactivity 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
6 months
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Time Frame: 12 weeks
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
12 weeks
Comparison of the effect of treatment with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Overactive Bladder Symptom Score (OABSS) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OABSS is a validated symptom questionnaire that sums the score of four symptoms (daytime frequency, nighttime frequency, urgency, and urgency incontinence). The total score ranges from 0 to 15, with higher the number, the greater the symptoms are.
6 months
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment
Time Frame: 12 weeks
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder after 12 weeks of treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
12 weeks
Comparison of the impact of symptoms on life with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment
Time Frame: 6 months
Individual participant change score on the Overactive Bladder Questionnaire short-form (OAB-q SF) will be compared between participants treated with Mirabegron and Solifenacin in patients with overactive bladder 6 months after treatment. The OAB-q SF assess the impact of OAB symptoms on the patient's life, and consists of symptom-bother and health-related quality of life. The subscales are summed and transformed into scores ranging from 0 to 100; a high symptom-bother score indicates greater symptom severity and a high health-related quality of life scale score indicates higher quality of life.
6 months
Effect on the participant's life after treatment with Mirabegron and Solifenacin after 12 weeks of treatment.
Time Frame: 12 weeks
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
12 weeks
Effect on the participant's life after treatment with Mirabegron and Solifenacin 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Short Form Health Survey (SF-12) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The score is converted to a range of 0 to 100, with high the score indicating a better quality of life.
6 months
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin after 12 weeks of treatment.
Time Frame: 12 weeks
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin after 12 weeks of treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
12 weeks
The participant's subjective measurement of treatment outcome with Mirabegron and Solifenacin 6 months after treatment.
Time Frame: 6 months
Individual participant's change score on Global Response Assessment Scale (GRAS) will be compared between participants treated with Mirabegron and Solifenacin 6 months after treatment. GRAS is a subjective outcome measurement to asses the participant's perception of treatment success. The score is scaled from 0 to 100%, with greater the percentage, the greater improvement of symptoms after treatment is perceived.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG3K2051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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