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

NCT04693897 | Unknown FDA Drug

• 1 other identifier: CMRPG3K2051
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder Syndrome; Detrusor Overactivity

Keywords

Overactive Bladder Syndrome; Mirabegron; Beta3-adrenoceptor agonist; Detrusor Overactivity; Urodynamics; Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in participant's urinary beta-3 adrenoreceptor from baseline to 12 weeks after treatment

  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 Outcomes (16)

• Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity after 12 weeks of treatment

  12 weeks

• Effect of treatment with Mirabegron in patients with overactive bladder with or without detrusor overactivity 6 months after treatment.

  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.

  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

  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.

  12 weeks

Study Arms (4)

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

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

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.

Interventions

Mirabegron 50 MG DRUG

Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome

Overactive bladder with Mirabegron

Solifenacin Succinate 5 MG DRUG

Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome

Overactive bladder with Solifenacin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (43)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ching-Chung Liang, MD

CONTACT

+886-3-3281200; ccjoliang@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share