An Experimental Protocol for the Study of Brain Functional Magnetic Resonance Imaging in Female With Urgent Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Brain regional gray matter density change of subjects
研究概览
简要总结
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 the prefrontal lobe and damage to the surrounding cerebral cortex leads to significant lower urinary tract dysfunction. Therefore, some scholars believe that urinary axis of the brain exist between the urinary system and the central nervous system, and the two are controlled by each other. Therefore, to study central conduction in patients with UUI and changes of physiology, pathology, brain chemical, brain structure in brain functional area caused by central sensitivity, in particular, changes in urine control cognition and midbrain limbic system (including memory function areas) in the brain, is beneficial to more in-depth understanding of its pathogenesis and treatment options. The Functional Magnetic Resonance Imaging provides a possibility for the study.
Method / design:Taking female UUI patients as target, through questionnaire survey, voiding diary, specialist physique, examination,ultrasonic examination of pelvic floor muscle, urodynamic examination and three sequence magnetic resonance scanning, after analyzing structural image of brian, resting functional images, dispersion tensor image, comparing with the normal control group and the female UUI group, before and after behavioral therapy in patients with UUI, and those who have no urinary incontinence and those who still have urinary incontinence after behavioral treatment, specific brain function biomarkers for female UUI patients are found and the brain function mechanism of the female UUI is to be explored in this project.
Discussion: This study breaks through the traditional limitations on the cause of incontinence.And it is the first time,the mental/behavior indicators of uui patients were combined with fMRI(Functional Magnetic Resonance Imaging) to explore biomarkers of brain and brain structural changes in patients .Then,it is becoming more and more important that the personalized treatment by building a UUI digital model using fMRI.
详细描述
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 volunteers and 50 UUI patients are recruited to carry out the related experimental research.This study had been approved by the Ethics Committee of the second affiliated Hospital of Wenzhou Medical University (No. LCK2019-291) .
1.50 UUI patients and 50 healthy volunteers who meet the inclusion criteria were selected.
(1) Approved by the Scientific Research Ethics Review Committee of the second affiliated Hospital of Wenzhou Medical University, 20- 70 years old female volunteers are recruited by studying advertising, reminding volunteers that the study is recruiting women with well bladder control function through the answer to the relevant questionnaires as a screening tool.
2.1 Healthy volunteers (n=50) should empty thier bladder first ；than they perform a fMRI scan.
2.2 The selected patients (n=50) will be inserted into 8F catheter for urine emptying, determination of bladder pressure and injection of aseptic water. First of all, the subjects empty their urine through the catheter, perform a fMRI scan first, and perform the following cycle module after the first scan is complete:①Paused for 11s ②.Injecting 22ml aquae sterilisata into bladder through catheter (completed in 11s ) ③.Paused for 11s ④.withdraw15ml liquid through catheter (completed in 11s ) , running 1-5 modules in circles until the subject issues a urination signal. With the subject's consent, the above cycle is repeated once, to exclude dropout who will be marked as a failure in the study. The rest of the patients completed the above circulation and patients with urine leakage scan the fMRI again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Brain regional gray matter density change of subjects
时间窗: Baseline,3th month
All subjects will be scanned by MRI for contrasting anatomic brain image，and the brain regional gray matter density will be calculated from the contrasting anatomical image.
Brain functional connectivity strength
时间窗: Baseline,3th month
All the subjects will be scanned by MRI for functional brain images，and the brain functional connectivity strengths will be calculated from the contrasting anatomical images,with number 1presents the maximum positive connectivity between two different brain regions,number-1presents maximum negative connectivity,and number 0 presents 0 connectivity. The change of brain connection intensity in three months.
Assessing change of the number of leakages was used to assess the severity of urinary incontinence.
时间窗: Baseline,3th month
By ues of voiding diaries.The more frequent leakage, the more serious incontinence. Baseline：
次要结局
- Assessing change of the number of millimeters of rectocele used to evaluate the prolapse of the posterior wall of the vagina.(Baseline,3th month)
- Assessing change of the number of millimeters of prolapse used to assess the extent of prolapse.(Baseline,3th month)
- Assessing change of POP-Q measurements were used to assess pelvic floor prolapse.(Baseline,3th month)
- Assessing change of the measurement of detrusor compliance was used to assist in the evaluation of acute incontinence.（By Urodynamic examination）(Baseline,3th month)
- Assessing change of the number of millimeters of cystocele used to evaluate the prolapse of the anterior wall of the vagina.(Baseline,3th month)
- Assessing change of Bladder neck mobility, used to assess the presence of stress urinary incontinence.(Baseline,3th month)