NCT07193823

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 15, 2025

Last Update Submit

September 22, 2025

Conditions

Keywords

multiple sclerosissexual dysfunctioncognitive dysfunctiondepressionanxietyoveractive bladderfatigue

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sexual dysfunction in female patients with multiple sclerosis

    At enrollment (Baseline, cross-sectional assessment)

Secondary Outcomes (1)

  • Association between sexual dysfunction and cognitive dysfunction, fatigue, depression, anxiety, and overactive bladder symptoms

    At enrollment (Baseline, cross-sectional assessment)

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patients with MS under follow-up at the Department of Neurology, Ege University.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Medicine, Department of Neurology

Izmir, Bornova, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingCognitive DysfunctionDepressionAnxiety DisordersUrinary Bladder, OveractiveFatigueSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases

Study Officials

  • Yesim Akkoc, M.D., Prof

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

    STUDY DIRECTOR

Central Study Contacts

Merve Dokumaci, Resident doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 26, 2025

Study Start

July 16, 2024

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations