Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473753
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-12-06
Brief Title:
Pelvic Floor Disorders in Multiple Sclerosis Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Clinical and Neurophysiological Assessment of Pelvic Floor Dysfunction in Patients With Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective
1 Clinical assessment of bowel bladder and sexual dysfunction in patients with MS
2 Impact of sphincter disorders on quality of life in patients with MS by using correlation between Extended Disability Status Scale EDSSand The Incontinence Quality of Life Questionnaire IQOL
Secondary objectives
-Studying the effect of low frequency rTMS on bladder symptoms in patients with MS
1 Clinical assessment of bowel bladder and sexual dysfunction in patients with MS
2 Impact of sphincter disorders on quality of life in patients with MS by using correlation between Extended Disability Status Scale EDSSand The Incontinence Quality of Life Questionnaire IQOL
Secondary objectives
-Studying the effect of low frequency rTMS on bladder symptoms in patients with MS
Detailed Description:
241- Type of the study This study will be a cross-section observational study 24 2- Study Setting neuology unit assuit university hospital 24 3- Study subjects From the neurologic outpatient clinic in Assiut University and patients referred from our staff members in Neuropsychiatry department
1 Inclusion criteria
Adult patient with definite Multiple sclerosis according to Mcdonalds Criteria revised criteria 2017 Age 18 years both sexes patient with subjective complaint of any of pelvic floor dysfunction bladder sexual or bowel
2 Exclusion criteria
Patients with other systemic or neurological disorder affecting sphincter Diabetes Mellitus Renal diseases Urinary tract infection epilepsy peripheral neuropathy irritable bowel syndrome Patients taking drugs affecting sphincter as psychotropic drugs
244 -Study tools in detail eg lab methods instruments steps chemicals Step I Patients will be assessed through full neurological history and examination with
All of them will be subjected to the following scales
Extended Disability Status Scale EDSS
Multiple Sclerosis Quality of Life Inventory MSQLI
Actionable Bladder Symptom Screening Tool ABSST
Neurogenic Bladder Symptom Score NBSS
The Incontinence Quality of Life Questionnaire IQOL
Neurogenic Bowel Dysfunction Score NBD
Multiple sclerosis intimacy and sexuality questionnaire 19-item version MSISQ-19 Step II All patients will have the paraclinical assessment in form of neuroimaging recent MRI brain and spine within last year evoked potentials visual auditory brainstem Motor evoked potential using TMS with parameters gained using single pulse paradigm Step III as a fulfillment for our secondary objective regarding the study of the effect of rTMS on urinary dysfunction we will recruit 20 patients with significant urinary dysfunction according to assessment results with EDSS 6 and they will be randomized in two arms for active and sham application of rTMS by using high intensity low frequency protocol for rTMS application39 for 10 sessions over two weeks with using voiding diary specific selected scales and selected cortical excitability measures as assessment tools we will follow up the patients immediately and for one month post sessions
1 Inclusion criteria
Adult patient with definite Multiple sclerosis according to Mcdonalds Criteria revised criteria 2017 Age 18 years both sexes patient with subjective complaint of any of pelvic floor dysfunction bladder sexual or bowel
2 Exclusion criteria
Patients with other systemic or neurological disorder affecting sphincter Diabetes Mellitus Renal diseases Urinary tract infection epilepsy peripheral neuropathy irritable bowel syndrome Patients taking drugs affecting sphincter as psychotropic drugs
244 -Study tools in detail eg lab methods instruments steps chemicals Step I Patients will be assessed through full neurological history and examination with
All of them will be subjected to the following scales
Extended Disability Status Scale EDSS
Multiple Sclerosis Quality of Life Inventory MSQLI
Actionable Bladder Symptom Screening Tool ABSST
Neurogenic Bladder Symptom Score NBSS
The Incontinence Quality of Life Questionnaire IQOL
Neurogenic Bowel Dysfunction Score NBD
Multiple sclerosis intimacy and sexuality questionnaire 19-item version MSISQ-19 Step II All patients will have the paraclinical assessment in form of neuroimaging recent MRI brain and spine within last year evoked potentials visual auditory brainstem Motor evoked potential using TMS with parameters gained using single pulse paradigm Step III as a fulfillment for our secondary objective regarding the study of the effect of rTMS on urinary dysfunction we will recruit 20 patients with significant urinary dysfunction according to assessment results with EDSS 6 and they will be randomized in two arms for active and sham application of rTMS by using high intensity low frequency protocol for rTMS application39 for 10 sessions over two weeks with using voiding diary specific selected scales and selected cortical excitability measures as assessment tools we will follow up the patients immediately and for one month post sessions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: