Sexual Dysfunction Prevalence and Its Relationship With Various Factors in Women With Multiple Sclerosis
Conditions: Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Fatigue in Multiple Sclerosis, Sexual Disfunction, Cognitive Dysfunction, Depression, Anxiety, Overactive Bladder, Fatigue
Sponsor: Ege University

Study Protocol 
Date: September 22, 2025 
1. Title Page 
Organization’s Unique Protocol ID: 24-5.1T/1 
Brief Title: Sexual Dysfunction in Women with Multiple Sclerosis (MS) 
Acronym: MS 
Official Title: Sexual Dysfunction Prevalence and Its Relationship with Various Factors in 
Women with Multiple Sclerosis 
Protocol Version and Date: Version 1.0 – September 2025 
Principal Investigator: Merve Dokumaci, Resident Doctor, Department of Physical Medicine 
and Rehabilitation 
Institution: Ege University, Faculty of Medicine 
2. Background and Rationale 
Sexual dysfunction in women with multiple sclerosis (MS) is an important but often 
overlooked issue.  
It significantly affects quality of life, relationships, and psychological well-being. Despite its 
impact, sexual dysfunction in MS remains under-researched and underdiagnosed. 
The primary aim of this study is to determine the prevalence of sexual dysfunction among 
female patients with MS.  
The secondary aim is to investigate the associations between sexual dysfunction and other 
clinical parameters such as cognitive dysfunction, fatigue, depression, anxiety, and 
overactive bladder symptoms. 
3. Objectives 
Primary Objective: To determine the prevalence of sexual dysfunction in female patients 
with MS. 
Secondary Objectives: To evaluate the association between sexual dysfunction and: 
- Cognitive dysfunction 
- Fatigue 
- Depression and anxiety 
- Overactive bladder symptoms 

4. Study Design 
Study Type: Observational 
Observational Model: Cohort 
Time Perspective: Cross-sectional 
Recruitment Status: Recruiting 
Study Start Date: July 16, 2024 (Actual) 
Primary Completion Date: October 2025 (Anticipated) 
Study Completion Date: November 2025 (Anticipated) 
5. Study Population and Eligibility 
Sex: Female 
Age Range: 25–50 years 
Sampling Method: Non-probability sample 
Inclusion Criteria: 
- Female patients aged 25–50 years 
- Literate and able to comprehend written and spoken instructions 
- Diagnosed with relapsing-remitting form of MS 
- 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 instructions 
- Absence of a continuous/regular sexual partner 
- EDSS score > 5 
- Not sexually active within the past 3 months 
- Spasticity level ≥ grade 2 (Modified Ashworth Scale) 
6. Sample Size and Statistical Considerations 
To estimate prevalence of sexual dysfunction with a 95% confidence interval (±10% width) 
for expected frequencies of 70%, 75%, and 80%,  
the required minimum sample sizes were calculated as 91, 82, and 72 patients, respectively. 
For examining the association between sexual dysfunction and cognitive dysfunction, 
power analysis was performed using the Mann-Whitney U test for two independent groups.  
With a two-sided test at a significance level of 0.05 and a medium effect size (d=0.23), a 
total of 134 participants (67+67) are required to achieve 80% power.  
Calculations were conducted using G*Power 3.1.9.4 software. 

Based on these estimations, the planned enrollment is 140 patients to ensure adequate 
power for both prevalence and association analyses. 
7. Study Procedures 
All assessments will be conducted face-to-face at enrollment during a single study visit. The 
following validated instruments will be applied: 
- Female Sexual Function Index (FSFI) 
- Brief International Cognitive Assessment for MS (BICAMS) 
- Hospital Anxiety and Depression Scale (HADS) 
- Fatigue Severity Scale (FSS) 
In addition, demographic data, clinical history, disease duration, and Expanded Disability 
Status Scale (EDSS) scores will be recorded. 
8. Outcome Measures 
Primary Outcome Measure: 
- Outcome: Prevalence of sexual dysfunction in female patients with MS 
- Time Frame: At enrollment (Baseline, cross-sectional assessment) 
Secondary Outcome Measures: 
- Outcome: Association between sexual dysfunction and cognitive dysfunction, fatigue, 
depression, anxiety, and overactive bladder symptoms 
- Time Frame: At enrollment (Baseline, cross-sectional assessment) 
9. Ethical Considerations 
Ethics Committee Approval: Ege University Faculty of Medicine Clinical Research Ethics 
Committee 
Approval Number: 2024-2411 
Approval Status: Approved 
Board Affiliation: Ege University Faculty of Medicine 
Board Contact: 
- Phone: +90 232 390 2134 
- Email: egetaek@gmail.com 
- Address: Ege University Faculty of Medicine 
All participants will provide written informed consent before study entry.  
Patient confidentiality and data protection standards will be ensured throughout the study. 
10. Locations 
Facility Name: Ege University Faculty of Medicine, Department of Neurology 
City: Izmir, Bornova 

Country: Turkey 
Recruitment Status: Recruiting