Sexual Dysfunction in Women With Multiple Sclerosis (MS)

NCT ID: NCT07193823

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-16

Study Completion Date

2025-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting Fatigue in Multiple Sclerosis Sexual Disfunction Cognitive Dysfunction Depression Anxiety Overactive Bladder Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ege University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merve Dokumaci

Resident Doctor, Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yesim Akkoc, M.D., Prof

Role: STUDY_DIRECTOR

Ege University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ege University Faculty of Medicine, Department of Neurology

Izmir, Bornova, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merve Dokumaci, Resident doctor

Role: CONTACT

+905435088428

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-5.1T/1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

My MS and My Menstrual Cycle
NCT06832293 RECRUITING
Study of Empathy in MS
NCT05332951 COMPLETED
L Test in Multiple Sclerosis
NCT05325359 UNKNOWN