MedTrace Logo

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

NCT04271852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-18

No results posted yet for this study

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

Interventions

DEVICE

bio-feedback treatment

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271852 on ClinicalTrials.gov