Multiple SclerosisNCT07236684
Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity
An observational study of Multiple Sclerosis, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to explore the link between urinary incontinence (UI) severity in patients with multiple sclerosis (PwMS), electromyography (EMG) findings, and other relevant factors. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- Women only
- Adult
Study population: Women diagnosed with MS will be included in the study.
Who may be able to join
- having an MS diagnosis according to the 2017 revised McDonald criteria,
- experiencing symptoms of UI as defined by the International Continence Society (ICS),
- having an EDSS score below 6.5,
- PwMS with no communication issues.
Who cannot join
- PwMS who did not give consent to participate,
- those with medication changes in the past 6 months,
- pregnant PwMS,
- recent vaginal or caesarean deliveries within 6 months,
- pelvic organ prolapse,
- urinary tract infection,
- recent attack history in the past month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul
Zeynep Yıldız Kızkın
About this study
Official title: Identification of Factors Related to Urinary Incontinence in Patients With Multiple Sclerosis and Electromyographic Assessment of Pelvic Floor Muscle Activity: A Cross-Sectional Study
The study aimed to explore the link between urinary incontinence (UI) severity in patients with multiple sclerosis (PwMS), electromyography (EMG) findings, and other relevant factors.
Read the detailed description
The study will consist of a cross-sectional observational analysis involving a cohort of 47 PwMS. The assessment will be employed various instruments, including the Expanded Disability Status Scale (EDSS), Neurogenic Bladder Symptom Score (NBSS), International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), EMG.
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, electromyography, urinary incontinence, pelvic floor, fatigue
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis (PwMS) | Adults diagnosed with multiple sclerosis will be included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded disability status scale (EDSS)
The Expanded disability status scale (EDSS) will be assessed disability and progression in PwMS, with scores from 0 (normal neurological exam) to 10 (death from MS). Higher scores indicate greater disability.
Measured: Single assessment at enrollment
Neurogenic Bladder Symptom Score (NBSS)
Storage, voiding, and complication symptoms of neurogenic bladder will be assessed with the Neurogenic Bladder Symptom Score (NBSS), a 24-item questionnaire covering incontinence, storage and voiding, and outcomes.
Measured: Single assessment at enrollment
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
The frequency and amount of leakage will be assessed using a six-item scale, and urinary incontinence will be categorised into four groups: mild (1-5), moderate (6-12), severe (13-18) and very severe.
Measured: Single assessment at enrollment
Incontinence Impact Questionnaire (IIQ-7)
Urinary symptoms' impact on daily activities was assessed with the Incontinence Impact Questionnaire (IIQ-7). The 7-item Likert scale has a score range of 0-21, with higher scores reflecting an increased negative impact of incontinence on social functioning, quality of life, and physical activity.
Measured: Single assessment at enrollment
Pelvic Floor Muscle Activity
An electromyography (EMG) device with surface electrodes will be used to assess pelvic floor muscle (PFM) activity. Patients received training beforehand, and measurements were taken noninvasively with two electrodes around the perineum and vagina and one on the inner thigh in women.
Measured: Single assessment at enrollment
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) assesses the frequency and duration of vigorous, moderate, and walking-like activities over a week. The values are multiplied by factors of 8, 4, and 3.3 Metabolic Equivalent of Tasks, respectively, to help measure overall physical activity. The minimum score for the IPAQ is 0, while there is no theoretically determined maximum score. Higher scores are associated with the individual engaging in a higher level of physical activity.
Measured: Single assessment at enrollment
Fatigue severity scale (FSS)
Fatigue severity scale (FSS) assesses fatigue severity in MS with nine items rated on a 7-point Likert scale. The mean score, adapted to Turkish society, indicates pathological fatigue if it is 4 or higher.
Measured: Single assessment at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start9 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yıldız Kızkın, Artvin Coruh University
- Investigators
- Zeynep Yıldız Kızkın, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236684
- Sponsor's protocol ID
- EMG MS
- Status last verified
- Mar 2026
- First submitted
- 15 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zecca C, Riccitelli GC, Disanto G, Singh A, Digesu GA, Panicari L, Puccini F, Mattioli M, Tubaro A, Gobbi C. Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients' quality of life. Eur J Neurol. 2016 Jul;23(7):1228-34. doi: 10.1111/ene.13010. Epub 2016 Apr 27.
PubMed 27120000Tornic J, Panicker JN. The Management of Lower Urinary Tract Dysfunction in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2018 Jun 28;18(8):54. doi: 10.1007/s11910-018-0857-z.
PubMed 29956001Afshari P, Abedi P, Majdinasab N, Tafakh S, Haghighizadeh M. Strengths of pelvic floor muscles in women with multiple sclerosis and its relationship with urinary incontinence and quality of life. Front Neurol. 2025 Jan 13;15:1514157. doi: 10.3389/fneur.2024.1514157. eCollection 2024.
PubMed 39871990
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Related to Urinary Incontinence in Patients With Multiple Sclerosis and Electromyographic Assessment of Pelvic Floor Muscle Activity: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07236684
- Acronym / sponsor ID
- EMG MS
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, electromyography, urinary incontinence, pelvic floor, fatigue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
The study aimed to explore the link between urinary incontinence (UI) severity in patients with multiple sclerosis (PwMS), electromyography (EMG) findings, and other relevant factors.
Detailed description
The study will consist of a cross-sectional observational analysis involving a cohort of 47 PwMS. The assessment will be employed various instruments, including the Expanded Disability Status Scale (EDSS), Neurogenic Bladder Symptom Score (NBSS), International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), International Physical Activity Questionnaire (IPAQ), Fatigue Severity Scale (FSS), EMG.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis (PwMS) | – | –Adults diagnosed with multiple sclerosis will be included in the study. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women diagnosed with MS will be included in the study.
Key inclusion criteria (4 listed)
- having an MS diagnosis according to the 2017 revised McDonald criteria,
- experiencing symptoms of UI as defined by the International Continence Society (ICS),
- having an EDSS score below 6.5,
- PwMS with no communication issues.
Key exclusion criteria (7 listed)
- PwMS who did not give consent to participate,
- those with medication changes in the past 6 months,
- pregnant PwMS,
- recent vaginal or caesarean deliveries within 6 months,
- pelvic organ prolapse,
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
Expanded disability status scale (EDSS)
Time frame: Single assessment at enrollment
The Expanded disability status scale (EDSS) will be assessed disability and progression in PwMS, with scores from 0 (normal neurological exam) to 10 (death from MS). Higher scores indicate greater disability.
Neurogenic Bladder Symptom Score (NBSS)
Time frame: Single assessment at enrollment
Storage, voiding, and complication symptoms of neurogenic bladder will be assessed with the Neurogenic Bladder Symptom Score (NBSS), a 24-item questionnaire covering incontinence, storage and voiding, and outcomes.
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: Single assessment at enrollment
The frequency and amount of leakage will be assessed using a six-item scale, and urinary incontinence will be categorised into four groups: mild (1-5), moderate (6-12), severe (13-18) and very severe.
Incontinence Impact Questionnaire (IIQ-7)
Time frame: Single assessment at enrollment
Urinary symptoms' impact on daily activities was assessed with the Incontinence Impact Questionnaire (IIQ-7). The 7-item Likert scale has a score range of 0-21, with higher scores reflecting an increased negative impact of incontinence on social functioning, quality of life, and physical activity.
Pelvic Floor Muscle Activity
Time frame: Single assessment at enrollment
An electromyography (EMG) device with surface electrodes will be used to assess pelvic floor muscle (PFM) activity. Patients received training beforehand, and measurements were taken noninvasively with two electrodes around the perineum and vagina and one on the inner thigh in women.
International Physical Activity Questionnaire (IPAQ)
Time frame: Single assessment at enrollment
The International Physical Activity Questionnaire (IPAQ) assesses the frequency and duration of vigorous, moderate, and walking-like activities over a week. The values are multiplied by factors of 8, 4, and 3.3 Metabolic Equivalent of Tasks, respectively, to help measure overall physical activity. The minimum score for the IPAQ is 0, while there is no theoretically determined maximum score. Higher scores are associated with the individual engaging in a higher level of physical activity.
Fatigue severity scale (FSS)
Time frame: Single assessment at enrollment
Fatigue severity scale (FSS) assesses fatigue severity in MS with nine items rated on a 7-point Likert scale. The mean score, adapted to Turkish society, indicates pathological fatigue if it is 4 or higher.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 27120000Zecca C, Riccitelli GC, Disanto G, Singh A, Digesu GA, Panicari L, Puccini F, Mattioli M, Tubaro A, Gobbi C. Urinary incontinence in multiple sclerosis: prevalence, severity and impact on patients' quality of life. Eur J Neurol. 2016 Jul;23(7):1228-34. doi: 10.1111/ene.13010. Epub 2016 Apr 27.
- Background: PubMed 29956001Tornic J, Panicker JN. The Management of Lower Urinary Tract Dysfunction in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2018 Jun 28;18(8):54. doi: 10.1007/s11910-018-0857-z.
- Background: PubMed 39871990Afshari P, Abedi P, Majdinasab N, Tafakh S, Haghighizadeh M. Strengths of pelvic floor muscles in women with multiple sclerosis and its relationship with urinary incontinence and quality of life. Front Neurol. 2025 Jan 13;15:1514157. doi: 10.3389/fneur.2024.1514157. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Zeynep Yıldız Kızkın principal investigator
Artvin Coruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep Yıldız Kızkın (5346945085 ext. +90, pt.zeynepyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded disability status scale (EDSS) (time frame: Single assessment at enrollment). The study lists 7 primary outcomes in all. 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 NCT07236684, which also lists 3 linked publications.
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 23 Mar 2026.