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

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.

• mirabegron (Drug), also known as Betmiga: use beta-3 agonist for sjogren syndrome patient
• oxybutynin, tolterodine, solifenacin (Drug), also known as Ditropan, tartrate, vesicare: use anti-muscarinic agent for patient with overactive bladder syndrome

Primary outcomes

• Overactive bladder symptom score [3 months]: 0-15, higher means worse outcome

Secondary outcomes

• uroflowmetry [3 months]: curve shape
• Frequency of void [3 months]: defined as the number of voiding per day
• International Prostate Symptom Score [3 months]: 0-35, with higher means worse outcome
• EULAR Sjogren's Syndrome Patient Reported Index [3 months]: 0-30, with higher means worse outcome
• Post-void residual [3months]: the residual bladder volume after voiding, in mL
• Average speed [3months]: in ml/s, the average speed of voiding as measured by uroflowmetry

Sex: All, ages: 20 Years to any

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