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

Primary Purpose

Sjogren's Syndrome, Overactive Bladder Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
mirabegron
oxybutynin, tolterodine, solifenacin
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sjogren's Syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antimuscarinic

B3-agonist

Arm Description

oxybutynin, tolterodine, solifenacin

mirabegron

Outcomes

Primary Outcome Measures

Overactive bladder symptom score
0-15, higher means worse outcome

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2021
Last Updated
August 8, 2021
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04909255
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome, Overactive Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antimuscarinic
Arm Type
Active Comparator
Arm Description
oxybutynin, tolterodine, solifenacin
Arm Title
B3-agonist
Arm Type
Experimental
Arm Description
mirabegron
Intervention Type
Drug
Intervention Name(s)
mirabegron
Other Intervention Name(s)
Betmiga
Intervention Description
use beta-3 agonist for sjogren syndrome patient
Intervention Type
Drug
Intervention Name(s)
oxybutynin, tolterodine, solifenacin
Other Intervention Name(s)
Ditropan, tartrate, vesicare
Intervention Description
use anti-muscarinic agent for patient with overactive bladder syndrome
Primary Outcome Measure Information:
Title
Overactive bladder symptom score
Description
0-15, higher means worse outcome
Time Frame
3 months
Secondary Outcome Measure Information:
Title
uroflowmetry
Description
curve shape
Time Frame
3 months
Title
Frequency of void
Description
defined as the number of voiding per day
Time Frame
3 months
Title
International Prostate Symptom Score
Description
0-35, with higher means worse outcome
Time Frame
3 months
Title
EULAR Sjogren's Syndrome Patient Reported Index
Description
0-30, with higher means worse outcome
Time Frame
3 months
Title
Post-void residual
Description
the residual bladder volume after voiding, in mL
Time Frame
3months
Title
Average speed
Description
in ml/s, the average speed of voiding as measured by uroflowmetry
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Xiang Cen, MD
Phone
(04)2205 - 2121
Ext
224043
Email
lylemushroom@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chieh-Lung Chou, MD
Phone
(04)2205 - 2121
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40421
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Xiang Chen, MD
Phone
(04)2205 - 2121
Ext
224043
Email
lylemushroom@gmail.com
First Name & Middle Initial & Last Name & Degree
Chieh-lung Chou, MD

12. IPD Sharing Statement

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

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