Status:
UNKNOWN
An Experimental Protocol for the Study of Brain Functional Magnetic Resonance Imaging in Female With Urgent Urinary Incontinence
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsors:
Northwestern University
Conditions:
Urinary Incontinence, Urge
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief Summary
Background: Patients' life quality and physical and mental health are seriously affected by Urgent Urinary Incontinence(UUI). The cause is not clear at present. It has been found that the injury of th...
Detailed Description
The study is a randomized controlled trial that study on the mechanism of brain function in women with urgent urinary incontinence by using fMRI. According to the exclusion criteria, 50 healthy volunt...
Eligibility Criteria
Inclusion
- People in the group should meet the following inclusion criteria:
- 20-70 years old, medical history ≥ 3 months.
- According to International Continence Society, ICS, people in the group should be patients diagnosed with UUI.
Exclusion
- Exclusion standards should be met by both patient group and the control group ( Not included in if meeting one of the following items ):
- Scan contraindication ：（1）reactive metal.(2)cardiac pacemaker.(3)magnetic implantation.(3)no spring steel wire in eyelid.(4)artificial cochlea.(5)electrodes/wires, pregnancy, etc.
- Patients with severe organ diseases ：·（1）liver disease.(2)lung disease.(3)kidney disease.(4)Other diseases that may interfere with the effectiveness and safety assessment of the test or may place the patient at some particular risk.
- People who is unable to cooperate with each other.
- A neurological or other medical disease that affects the function of the central nervous system ：（1） anemia.（2） vitamin B12 deficiency .（3）folic acid deficiency.
- People who abuse drug.
- People who has dependence history
- Hyperthyroidism in active period
- cerebrovascular disease (e.g. transient ischemic attack, ischemic or hemorrhagic stroke, aneurysm)
- Central nervous system infection
- Alcoholic dementia
- Uncontrolled epilepsy
- Autoimmune disease
- Diabetes mellitus
- Detrusor hyperreflexia (cystitis, tuberculosis, tumor, stone, bladder outlet obstruction) and other organic lesion.
Key Trial Info
Start Date :
October 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04271852
Start Date
October 23 2019
End Date
December 31 2022
Last Update
March 18 2020
Active Locations (1)
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1
Department of Gynecology of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000