Sexual Dysfunction in Women With Multiple Sclerosis (MS)

Recruiting

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

• Registration Number: NCT07193823
• Lead Sponsor: Ege University

Brief 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. 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

Not available

Study Timeline

• Study Start: 2024-07-16
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-10
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of sexual dysfunction in female patients with multiple sclerosis	At enrollment (Baseline, cross-sectional assessment)

Secondary Outcome Measures

Name	Time	Method
Association between sexual dysfunction and cognitive dysfunction, fatigue, depression, anxiety, and overactive bladder symptoms	At enrollment (Baseline, cross-sectional assessment)

Trial Locations

Locations (1)

Ege University Faculty of Medicine, Department of Neurology; Izmir, Bornova, Turkey (Türkiye)