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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Detrusor Overactivity; Overactive Bladder Syndrome

Treatments: Drug: Solifenacin Succinate 5 MG; Drug: Mirabegron 50 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04693897

CMRPG3K2051

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 4 patient groups

Overactive bladder with Mirabegron

Description:

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.

Treatment:

Drug: Mirabegron 50 MG

Overactive bladder with Solifenacin

Description:

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.

Treatment:

Drug: Solifenacin Succinate 5 MG

Urinary tract infection

Description:

Urinary samples for beta-3 adrenoceptor concentration of 100 patients with urinary tract infection.

Control

Description:

Urinary samples for beta-3 adrenoceptor concentration of 100 patients without lower urinary tract symptoms.