Pelvic Floor Disorders in Multiple Sclerosis Patients

Clinical and Neurophysiological Assessment of Pelvic Floor Dysfunction in Patients With Multiple Sclerosis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Yosra Abdallah; Phone Number: +201028794068; Email: yoya96790@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed with multiple sclerosis according to McDonald's criteria 2017 attending outpatient clinic, department of neurology and psychiatry, Assuit university hospital

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales	Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor evoked potential using TMS with parameters gained using single pulse paradigm	Motor evoked potential using TMS with parameters gained using single pulse paradigm effect on sphincter distrubance in multiple sclerosis.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Belbasis L, Bellou V, Evangelou E, Tzoulaki I. Environmental factors and risk of multiple sclerosis: Findings from meta-analyses and Mendelian randomization studies. Mult Scler. 2020 Apr;26(4):397-404. doi: 10.1177/1352458519872664. Epub 2019 Sep 6.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: M.s pelvic floor disorders

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL