Multiple SclerosisMSNCT07193823
Sexual Dysfunction in Women With Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis and Multiple Sclerosis (MS) - Relapsing-remitting, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Sexual dysfunction in women with multiple sclerosis (MS) is an important yet often overlooked problem. The primary objective of this study is to investigate the prevalence of sexual dysfunction in female patients diagnosed with MS. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Fatigue in Multiple Sclerosis
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2024to Nov 2025
- 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 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with MS under follow-up at the Department of Neurology, Ege University.
Who may be able to join
- Female patients aged 25-50 years
- Literate and able to comprehend written and spoken instructions
- Diagnosed with relapsing-remitting form of multiple sclerosis
- Having a continuous/regular sexual partner
- Expanded Disability Status Scale (EDSS) score ≤ 5
- At least 3 months since the last relapse
- Sexually active within the past 3 months
- Spasticity level < grade 2 according to the Modified Ashworth Scale
Who cannot join
- Pregnancy
- Illiteracy or inability to understand spoken or written instructions
- Absence of a continuous/regular sexual partner
- Expanded Disability Status Scale (EDSS) score > 5
- Not sexually active within the past 3 months
- Spasticity level ≥ grade 2 according to the Modified Ashworth Scale
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
Ege University Faculty of Medicine, Department of Neurology
Izmir, Bornova, 35100
About this study
Official title: Sexual Dysfunction Prevalence and Its Relationship With Various Factors in Women With Multiple Sclerosis
Sexual dysfunction in women with multiple sclerosis (MS) is an important yet often overlooked problem. The primary objective of this study is to investigate the prevalence of sexual dysfunction in female patients diagnosed with MS. The secondary objective is to evaluate the relationship between sexual dysfunction and fatigue, depression, anxiety, overactive bladder symptoms, and cognitive dysfunction.
For this purpose, the following validated instruments will be used: the Female Sexual Function Index (FSFI) to assess sexual dysfunction, the Brief International Cognitive Assessment for MS (BICAMS) to evaluate cognitive function, the Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, the Fatigue Severity Scale (FSS) to measure fatigue, and the Overactive Bladder Questionnaire (OAB-V8) to evaluate overactive bladder symptoms.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Fatigue in Multiple Sclerosis, Sexual Disfunction, Cognitive Dysfunction, Depression
- Keywords
- multiple sclerosis, sexual dysfunction, cognitive dysfunction, depression, anxiety, overactive bladder, fatigue
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Cognitive Dysfunction, Depression, Anxiety Disorders, Urinary Bladder, Overactive, Fatigue, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sexual dysfunction in female patients with multiple sclerosis
Measured: At enrollment (Baseline, cross-sectional assessment)
Secondary outcomes (1)
Association between sexual dysfunction and cognitive dysfunction, fatigue, depression, anxiety, and overactive bladder symptoms
Measured: At enrollment (Baseline, cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start16 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Dokumaci, Ege University
- Investigators
- Yesim Akkoc, M.D., Prof, Study director, Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193823
- Sponsor's protocol ID
- 24-5.1T/1
- Acronym
- MS
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction Prevalence and Its Relationship With Various Factors in Women With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07193823
- Acronym / sponsor ID
- MS / 24-5.1T/1
- Conditions
- Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Fatigue in Multiple Sclerosis, Sexual Disfunction, Cognitive Dysfunction, Depression
- Keywords
- multiple sclerosis, sexual dysfunction, cognitive dysfunction, depression, anxiety, overactive bladder, fatigue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 26 Sep 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.
Sexual dysfunction in women with multiple sclerosis (MS) is an important yet often overlooked problem. The primary objective of this study is to investigate the prevalence of sexual dysfunction in female patients diagnosed with MS. The secondary objective is to evaluate the relationship between sexual dysfunction and fatigue, depression, anxiety, overactive bladder symptoms, and cognitive dysfunction.
For this purpose, the following validated instruments will be used: the Female Sexual Function Index (FSFI) to assess sexual dysfunction, the Brief International Cognitive Assessment for MS (BICAMS) to evaluate cognitive function, the Hospital Anxiety and Depression Scale (HADS) to assess depression and anxiety, the Fatigue Severity Scale (FSS) to measure fatigue, and the Overactive Bladder Questionnaire (OAB-V8) to evaluate overactive bladder symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients with MS under follow-up at the Department of Neurology, Ege University.
Key inclusion criteria (8 listed)
- Female patients aged 25-50 years
- Literate and able to comprehend written and spoken instructions
- Diagnosed with relapsing-remitting form of multiple sclerosis
- Having a continuous/regular sexual partner
- Expanded Disability Status Scale (EDSS) score ≤ 5
Key exclusion criteria (6 listed)
- Pregnancy
- Illiteracy or inability to understand spoken or written instructions
- Absence of a continuous/regular sexual partner
- Expanded Disability Status Scale (EDSS) score > 5
- Not sexually active within the past 3 months
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
Prevalence of sexual dysfunction in female patients with multiple sclerosis
Time frame: At enrollment (Baseline, cross-sectional assessment)
1 secondary outcome
Association between sexual dysfunction and cognitive dysfunction, fatigue, depression, anxiety, and overactive bladder symptoms
Time frame: At enrollment (Baseline, cross-sectional assessment)
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 26 Sep 2025.
- 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.
Yesim Akkoc, M.D., Prof study director
Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
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 Multiple Sclerosis (MS) - Relapsing-remitting, run by Ege 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 8 inclusion and 6 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 26 Sep 2025. 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 Merve Dokumaci, Resident doctor (+905435088428, dokumacimerve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sexual dysfunction in female patients with multiple sclerosis (time frame: At enrollment (Baseline, cross-sectional assessment)). 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 26 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.