An Experimental Protocol for the Study of Brain Functional Magnetic Resonance Imaging in Female With Urgent Urinary Incontinence

NCT04271852 | Unknown DMC

• 1 other identifier: SAHoWMU-CR2019-09-112
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Urinary Incontinence, Urge

Outcome Measures

Primary Outcomes (3)

• Assessing change of the number of leakages was used to assess the severity of urinary incontinence.

  By ues of voiding diaries.The more frequent leakage, the more serious incontinence. Baseline：

  Baseline,3th month

• Brain regional gray matter density change of subjects

  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.

  Baseline,3th month

• Brain functional connectivity strength

  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.

  Baseline,3th month

Secondary Outcomes (6)

• Assessing change of POP-Q measurements were used to assess pelvic floor prolapse.

  Baseline,3th month

• 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 the measurement of detrusor compliance was used to assist in the evaluation of acute incontinence.（By Urodynamic examination）

  Baseline,3th month

• Assessing change of Bladder neck mobility, used to assess the presence of stress urinary incontinence.

  Baseline,3th month

Other Outcomes (7)

• Positive and negative mood effect of subject

  Baseline,3th month

• PISQ-12 change of subjects

  Baseline,3th month

• I-QOL change of subjects

  Baseline,3th month

Study Arms (2)

UUI patients

EXPERIMENTAL

50 UUI patients will have biofeedback treatment once a week.

Device: bio-feedback treatment

Control

NO INTERVENTION

Interventions

bio-feedback treatment DEVICE

50 patients will treated with phenix u2 and phenix u4 treating equipment。

UUI patients

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Femal
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, medical history ≥ 3 months.
• According to International Continence Society, ICS, people in the group should be patients diagnosed with UUI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Northwestern University: collaborator

Study Sites (1)

Department of Gynecology of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ledan Wang, Doctor

CONTACT

13858850907; ledanwang331@163.com

Jiaorong Li, Master

CONTACT

19884692686; 2026634592@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: February 17, 2020
• Study Start: October 23, 2019
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)