Clinical trial NCT04909255: Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder
Official title: The Therapeutic Effect of Beta-3 Agonist and Anti-muscarinic Agent on Overactive Bladder Among Sjogren's Syndrome Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sjogren's Syndrome
Overactive Bladder Syndrome
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overactive bladder symptom score
timeFrame: 3 months
Secondary outcomes:
measure: uroflowmetry
timeFrame: 3 months
measure: Frequency of void
timeFrame: 3 months
measure: International Prostate Symptom Score
timeFrame: 3 months
measure: EULAR Sjogren's Syndrome Patient Reported Index
timeFrame: 3 months
measure: Post-void residual
timeFrame: 3months
measure: Average speed
timeFrame: 3months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: