Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder
- Conditions
- Sjogren's SyndromeOveractive Bladder Syndrome
- Interventions
- Registration Number
- NCT04909255
- Lead Sponsor
- China Medical University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Diagnosis of Sjogren's syndrome AND
- Clinical diagnosis of OAB
- Congenital or acquired anatomic abnormalities of the genitourinary tract,
- Uncontrolled severe hypertension >180 mmHg
- Cannot cooperate for voiding diary documentation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antimuscarinic oxybutynin, tolterodine, solifenacin oxybutynin, tolterodine, solifenacin B3-agonist mirabegron mirabegron
- Primary Outcome Measures
Name Time Method Overactive bladder symptom score 3 months 0-15, higher means worse outcome
- Secondary Outcome Measures
Name Time Method EULAR Sjogren's Syndrome Patient Reported Index 3 months 0-30, with higher means worse outcome
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
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
Trial Locations
- Locations (1)
China Medical University Hospital
🇨🇳Taichung, Taiwan