Sjogren's Syndrome Clinical Trial
Official title:
The Therapeutic Effect of Beta-3 Agonist and Anti-muscarinic Agent on Overactive Bladder Among Sjogren's Syndrome Patient
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
| Completed |
NCT04968912 -
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
|
Phase 2 | |
| Completed |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
| Completed |
NCT00809003 -
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
|
N/A | |
| Completed |
NCT00023491 -
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
|
N/A | |
| Completed |
NCT05005806 -
Fish Oil (Omega 3 ) in Sjogren's Syndrome
|
Phase 2/Phase 3 | |
| Enrolling by invitation |
NCT03436576 -
Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye
|
Phase 3 | |
| Terminated |
NCT04143841 -
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
|
N/A | |
| Completed |
NCT03611283 -
Topical Management of Xerostomia With Dry Mouth Products
|
N/A | |
| Recruiting |
NCT06104124 -
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
|
Phase 3 | |
| Recruiting |
NCT05115487 -
Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome
|
||
| Recruiting |
NCT06437652 -
An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome
|
||
| Recruiting |
NCT05383677 -
Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome
|
Phase 2 | |
| Not yet recruiting |
NCT03938207 -
Dry Eye Syndrome, Healthy Control, Sjögren's Syndrome and Other Inflammation Disease in Taiwan Biobank
|
||
| Completed |
NCT04239521 -
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
|
||
| Completed |
NCT04546542 -
Hydroxychloroquine Blood Levels in Primary Sjögren Syndrome Patients
|
||
| Recruiting |
NCT05085431 -
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
|
Early Phase 1 | |
| Completed |
NCT00565526 -
Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome
|
||
| Completed |
NCT01369589 -
An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness
|
Phase 1/Phase 2 | |
| Completed |
NCT00001953 -
The Functioning of Immune and Hormonal Systems in Patients With Sjogren's Syndrome and in Healthy Volunteers
|
N/A |