Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder

NCT ID: NCT04909255

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2022-08-15

Brief Summary

Overactive bladder is more prevalent among the Sjogren syndrome's population compare to the general population. Both anti-muscarinic agent and beta-3 agonist are recommended as second line treatment for overactive bladder syndrome. However, theoretically, undesirable effect of the anti-muscarinic agent such as dry mouth and constipation would make it less suitable for Sjogren syndrome patient with overactive bladder. Therefore, this study is a randomised control study with the aim to evaluate the therapeutic effect of beta-3 agonist and anti-muscarinic agent on overactive bladder among sjogren's syndrome patient.

Detailed Description

Overactive bladder(OAB) is a syndrome characterized by the presence of frequency, urgency, nocturia, and with or without urgency urinary incontinence. The reported prevalence of overactive bladder was similar between man and woman. An overactive bladder has been shown to impair the quality of life of the patient. Muscarinic receptors, particularly M2 and M3 receptors were involved in detrusor contraction. Anti-muscarinic receptor drugs, such as oxybutynin and tolterodine are drugs that are currently recommended by both European association of Urology(EAU) and American Urology Association(AUA) guidelines as a second-line treatment for OAB. Beta-3 agonist such as mirabegron is another medication that is commonly used for OAB. Beta-3 agonists increased the bladder capacity of OAB patients without impairing the detrusor contractility.

Sjogren syndrome(Ss) is an autoimmune disease that frequently affects the lacrimal gland and salivary gland causing the patient to have dry mouth and dry eyes. Extraglandular manifestation was also present. Genitourinary manifestation such as frequency, urgency, and vaginal dryness have been reported but not extensively studied. Currently, there is no consensus for the management of these extraglandular manifestations.

Several studies have reported an increasing prevalence of lower urinary tract symptoms in Ss. Detrusor overactivity was the most commonly found based on a small study. A nationwide population-based study in Taiwan has shown that the risk of developing OAB in the Ss population is significantly higher than the control group.

Cholinesterase inhibitors like pilocarpine and muscarinic agonists such as cevimeline are common drugs used to treat dry eyes and dry mouth of Sjogren syndrome while anti-muscarinic drugs are extensively used to treat OAB. Pilocarpine works by increasing acetylcholine concentration in the synaptic junction while cevimeline works as a muscarinic receptor. Whether the increased prevalence of OAB in Ss population is due to the medication itself or due to the disease is not clear. Currently, there is no study investigating the optimal management of lower urinary tract symptoms(LUTS) in Sjogren Syndrome populations.

Objective The objective of this study is to investigate the effect of muscarinic agonists used for Ss on LUTS and the efficacy of beta3 agonists for management OAB in Ss.

Conditions

Sjogren's Syndrome; Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antimuscarinic

oxybutynin, tolterodine, solifenacin

Group Type: ACTIVE_COMPARATOR

oxybutynin, tolterodine, solifenacin

Intervention Type: DRUG

use anti-muscarinic agent for patient with overactive bladder syndrome

B3-agonist

mirabegron

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

use beta-3 agonist for sjogren syndrome patient

Interventions

mirabegron

use beta-3 agonist for sjogren syndrome patient

Intervention Type: DRUG

oxybutynin, tolterodine, solifenacin

use anti-muscarinic agent for patient with overactive bladder syndrome

Intervention Type: DRUG

Other Intervention Names

Betmiga; Ditropan, tartrate, vesicare

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Sjogren's syndrome AND
• Clinical diagnosis of OAB

Exclusion Criteria

• Congenital or acquired anatomic abnormalities of the genitourinary tract,
• Uncontrolled severe hypertension >180 mmHg
• Cannot cooperate for voiding diary documentation

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hao Xiang Cen, MD

Role: CONTACT

lylemushroom@gmail.com

(04)2205 - 2121 ext. 224043

Chieh-Lung Chou, MD

Role: CONTACT

(04)2205 - 2121

Facility Contacts

Hao Xiang Chen, MD

Role: primary

lylemushroom@gmail.com

(04)2205 - 2121 ext. 224043

Chieh-lung Chou, MD

Role: backup

Other Identifiers

CMUH109-REC2-200

Identifier Type: -

Identifier Source: org_study_id