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

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ClinicalTrials.gov Identifier: NCT04693897
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ching-Chung Liang, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment
Overactive Bladder Syndrome Detrusor Overactivity Drug: Mirabegron 50 MG Drug: Solifenacin Succinate 5 MG

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: To Explore the Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and Develop Its Urinary Biomarker
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.


Biospecimen Retention:   Samples Without DNA
Urine


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT04693897


Contacts
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Contact: Ching-Chung Liang, MD +886-3-3281200 ext 8258 ccjoliang@cgmh.org.tw

Sponsors and Collaborators
Chang Gung Memorial Hospital
Publications of Results:

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Responsible Party: Ching-Chung Liang, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04693897    
Other Study ID Numbers: CMRPG3K2051
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ching-Chung Liang, Chang Gung Memorial Hospital:
Overactive Bladder Syndrome
Mirabegron
Beta3-adrenoceptor agonist
Detrusor Overactivity
Urodynamics
Biomarker
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solifenacin Succinate
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents