Multiple SclerosisMS-UI-PFMNCT07489794
URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS
An observational study of Multiple Sclerosis and Urinary Incontinence (UI), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Multiple Sclerosis, Urinary Incontinence (UI)
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 30 Oct 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
- No healthy volunteers
- Adult
Study population: The study will include female patients with multiple sclerosis (MS) aged 30-50 years, diagnosed according to the 2017 revised McDonald criteria, who experience urinary incontinence symptoms according to the International Continence Society (ICS) definition and have an EDSS score below 6.5. Participants must be able to communicate effectively. Patients who do not provide consent, have had a medication change within the last 6 months, are pregnant, have had a vaginal or cesarean delivery within the last 6 months, have pelvic organ prolapse, or have a urinary tract infection will be excluded.
Who may be able to join
- Diagnosis of multiple sclerosis (MS) according to the 2017 revised McDonald criteria.
- Female patients aged 30-50 years (age range with higher prevalence of urinary incontinence in MS).
- Experiencing urinary incontinence (UI) symptoms according to the International Continence Society (ICS) definition.
- EDSS (Expanded Disability Status Scale) score below 6.5.
- Patients with no communication difficulties. -
Who cannot join
- MS patients who do not provide consent to participate in the study.
- MS patients who have had a medication change within the last 6 months.
- Pregnant MS patients.
- History of vaginal or cesarean delivery within the last 6 months.
- Pelvic organ prolapse.
- Urinary tract infection
- -
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
Istanbul, Prof. Dr. Cemil Taşçıoğlu City Hospital, Turkey
Istanbul
Büşra Aydın Erkılıç, MSc, 905062214052, bsrr.aydinn@gmail.com
Büşra Aydın Erkılıç, MSc
About this study
Official title: FACTORS ASSOCIATED WITH URINARY INCONTINENCE AND EVALUATION OF PELVIC FLOOR MUSCLE ACTIVITY IN PATIENTS WITH MULTIPLE SCLEROSIS: CROSS-SECTIONAL STUDY
This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.
Read the detailed description
This study investigates the relationship between urinary incontinence (UI) severity and pelvic floor muscle activity in women with multiple sclerosis (MS). UI is common in MS and negatively affects quality of life, physical activity, and social participation. The study also explores how UI severity is associated with disability, fatigue, and overall quality of life.
Participants' demographic and clinical information, including age, disease duration, MS type, and disability level (measured by the Expanded Disability Status Scale, EDSS), will be recorded. Standardized questionnaires will assess urinary symptoms, their impact on daily life, physical activity, and fatigue. Pelvic floor muscle activity will be evaluated using surface electromyography (EMG) with biofeedback, conducted by trained physiotherapists.
The study will be conducted at the Pelvic Floor Health Center and is planned as a cross-sectional study. All assessments, including questionnaires and EMG measurements, are expected to take approximately 45 minutes per participant. Findings from this study aim to improve understanding of UI in women with MS and guide future interventions.
- Conditions
- Multiple Sclerosis, Urinary Incontinence (UI)
- Keywords
- multiple sclerosis, urinary incontinence, Electromyography, Fatigue, Physical Activity
- Medical subject headings
- Multiple Sclerosis, Urinary Incontinence, Fatigue, Motor Activity
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 |
|---|---|---|
| Observational Group | Participants will be observed for EMG activity, fatigue, physical activity, and urinary incontinence symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle activity with surface EMG
Evaluated using biofeedback-assisted surface EMG. Metrics recorded include mean EMG activity during contraction and rest phases, standard deviation of EMG activity, peak and minimum EMG values, contraction onset, and relaxation times
Measured: baseline
Secondary outcomes (4)
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Assesses severity and impact of urinary incontinence
Measured: baseline
Incontinence Impact Questionnaire (IIQ-7)
Evaluates the effect of urinary incontinence on quality of life
Measured: baseline
International Physical Activity Questionnaire (IPAQ)
Assesses participants' physical activity levels
Measured: baseline
Fatigue Severity Scale (FSS)
Measures severity of fatigue experienced by participants
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start9 Mar 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Aydin Erkilic, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489794
- Sponsor's protocol ID
- MS-UI-PFM-2026
- Acronym
- MS-UI-PFM
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FACTORS ASSOCIATED WITH URINARY INCONTINENCE AND EVALUATION OF PELVIC FLOOR MUSCLE ACTIVITY IN PATIENTS WITH MULTIPLE SCLEROSIS: CROSS-SECTIONAL STUDY
- ClinicalTrials.gov ID
- NCT07489794
- Acronym / sponsor ID
- MS-UI-PFM / MS-UI-PFM-2026
- Conditions
- Multiple Sclerosis, Urinary Incontinence (UI)
- Keywords
- multiple sclerosis, urinary incontinence, Electromyography, Fatigue, Physical Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
This study aims to investigate the relationship between urinary incontinence severity and surface electromyography (EMG) findings in women with multiple sclerosis. It will also examine the association of urinary incontinence with disability, quality of life, physical activity, and fatigue.
Detailed description
This study investigates the relationship between urinary incontinence (UI) severity and pelvic floor muscle activity in women with multiple sclerosis (MS). UI is common in MS and negatively affects quality of life, physical activity, and social participation. The study also explores how UI severity is associated with disability, fatigue, and overall quality of life.
Participants' demographic and clinical information, including age, disease duration, MS type, and disability level (measured by the Expanded Disability Status Scale, EDSS), will be recorded. Standardized questionnaires will assess urinary symptoms, their impact on daily life, physical activity, and fatigue. Pelvic floor muscle activity will be evaluated using surface electromyography (EMG) with biofeedback, conducted by trained physiotherapists.
The study will be conducted at the Pelvic Floor Health Center and is planned as a cross-sectional study. All assessments, including questionnaires and EMG measurements, are expected to take approximately 45 minutes per participant. Findings from this study aim to improve understanding of UI in women with MS and guide future interventions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | –Participants will be observed for EMG activity, fatigue, physical activity, and urinary incontinence symptoms. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include female patients with multiple sclerosis (MS) aged 30-50 years, diagnosed according to the 2017 revised McDonald criteria, who experience urinary incontinence symptoms according to the International Continence Society (ICS) definition and have an EDSS score below 6.5. Participants must be able to communicate effectively. Patients who do not provide consent, have had a medication change within the last 6 months, are pregnant, have had a vaginal or cesarean delivery within the last 6 months, have pelvic organ prolapse, or have a urinary tract infection will be excluded.
Key inclusion criteria (5 listed)
- Diagnosis of multiple sclerosis (MS) according to the 2017 revised McDonald criteria.
- Female patients aged 30-50 years (age range with higher prevalence of urinary incontinence in MS).
- Experiencing urinary incontinence (UI) symptoms according to the International Continence Society (ICS) definition.
- EDSS (Expanded Disability Status Scale) score below 6.5.
- Patients with no communication difficulties. -
Key exclusion criteria (7 listed)
- MS patients who do not provide consent to participate in the study.
- MS patients who have had a medication change within the last 6 months.
- Pregnant MS patients.
- History of vaginal or cesarean delivery within the last 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
Pelvic floor muscle activity with surface EMG
Time frame: baseline
Evaluated using biofeedback-assisted surface EMG. Metrics recorded include mean EMG activity during contraction and rest phases, standard deviation of EMG activity, peak and minimum EMG values, contraction onset, and relaxation times
4 secondary outcomes
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: baseline
Incontinence Impact Questionnaire (IIQ-7)
Time frame: baseline
International Physical Activity Questionnaire (IPAQ)
Time frame: baseline
Fatigue Severity Scale (FSS)
Time frame: baseline
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 24 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared with other researchers.
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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.
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 and Urinary Incontinence (UI), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 5 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 24 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 Büşra Aydın Erkılıç, MSc (905062214052, bsrr.aydinn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle activity with surface EMG (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.