Multiple SclerosisNCT06473753
Pelvic Floor Disorders in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Assiut University.
Trial 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 (EDSS)and The Incontinence Quality of Life Questionnaire (IQOL) Secondary… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient diagnosed with multiple sclerosis according to McDonald's criteria 2017 attending outpatient clinic, department of neurology and psychiatry, Assuit university hospital
Who may be able to join
- 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)
Who cannot join
- Patients with other systemic or neurological disorder affecting sphincter.
- Patients taking drugs affecting sphincter.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Neurophysiological Assessment of Pelvic Floor Dysfunction in Patients With Multiple Sclerosis
Primary objective
- Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS
- 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.
Read the 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.
- 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)
- 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosra Abdallah Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473753
- Sponsor's protocol ID
- M.s pelvic floor disorders
- Status last verified
- Jun 2024
- First submitted
- 6 Dec 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Individual data sharing
- Yes
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.
PubMed 32249718
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurophysiological Assessment of Pelvic Floor Dysfunction in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06473753
- Acronym / sponsor ID
- M.s pelvic floor disorders
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective
- Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS
- 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.
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.
- 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)
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with multiple sclerosis according to McDonald's criteria 2017 attending outpatient clinic, department of neurology and psychiatry, Assuit university hospital
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients with other systemic or neurological disorder affecting sphincter.
- Patients taking drugs affecting sphincter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales
Time frame: Baseline
Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales
1 secondary outcome
Motor evoked potential using TMS with parameters gained using single pulse paradigm
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 32249718Belbasis 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yosra Abdallah (+201028794068, yoya96790@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS though applying specific related scales (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.