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

NCT04909255 | Unknown Phase 4 FDA Drug

• 1 other identifier: CMUH109-REC2-200
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Overactive bladder symptom score

  0-15, higher means worse outcome

  3 months

Secondary Outcomes (6)

• uroflowmetry

  3 months

• Frequency of void

  3 months

• International Prostate Symptom Score

  3 months

• EULAR Sjogren's Syndrome Patient Reported Index

  3 months

• Post-void residual

  3months

Study Arms (2)

Antimuscarinic

ACTIVE COMPARATOR

oxybutynin, tolterodine, solifenacin

Drug: oxybutynin, tolterodine, solifenacin

B3-agonist

EXPERIMENTAL

mirabegron

Drug: mirabegron

Interventions

mirabegron DRUG

use beta-3 agonist for sjogren syndrome patient

Also known as: Betmiga

B3-agonist

oxybutynin, tolterodine, solifenacin DRUG

use anti-muscarinic agent for patient with overactive bladder syndrome

Also known as: Ditropan, tartrate, vesicare

Antimuscarinic

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Sjogren's syndrome AND
• Clinical diagnosis of OAB

You may not qualify if:

• Congenital or acquired anatomic abnormalities of the genitourinary tract,
• Uncontrolled severe hypertension \>180 mmHg
• Cannot cooperate for voiding diary documentation

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40421, Taiwan

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

mirabegron; oxybutynin; Tolterodine Tartrate; Solifenacin Succinate; tartaric acid

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Hao Xiang Cen, MD

CONTACT

(04)2205 - 2121; lylemushroom@gmail.com

Chieh-Lung Chou, MD

CONTACT

(04)2205 - 2121

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: June 1, 2021
• Study Start: March 23, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

TW (1)