Pelvic Floor Disorders in Multiple Sclerosis Patients

Assiut University

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT06473753

M.s pelvic floor disorders

Details and patient eligibility

About

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 (EDSS)and The Incontinence Quality of Life Questionnaire (IQOL)

Secondary objectives

-Studying the effect of low frequency rTMS on bladder symptoms in patients with MS.

Full description

2.4.1- Type of the study: This study will be a cross-section observational study. 2.4. 2- Study Setting: neuology unit assuit university hospital 2.4. 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 Mcdonald's 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

2.4.4 -Study tools (in detail, e.g., 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 application[39] 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1.Adult patient with definite Multiple sclerosis 2-Age > 18 years 3-both sexes 4-patient with complaint of any of pelvic floor dysfunction (bladder, sexual or bowel)

Exclusion criteria

1. Patients with other systemic or neurological disorder affecting sphincter.
2. Patients taking drugs affecting sphincter.