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Recruiting NCT07193823

Sexual Dysfunction in Women With Multiple Sclerosis (MS)

Observational Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting Fatigue in Multiple Sclerosis Sexual Disfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting, Fatigue in Multiple Sclerosis, Sexual Disfunction. Basic parameters: 25 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Sexual Dysfunction Prevalence and Its Relationship With Various Factors in Women With Multiple Sclerosis

Overview

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.

Primary outcome measures

  • Prevalence of sexual dysfunction in female patients with multiple sclerosis [Time frame: At enrollment (Baseline, cross-sectional assessment)]
Secondary outcome measures (1)
  • Association between sexual dysfunction and cognitive dysfunction, fatigue, depression, anxiety, and overactive bladder symptoms [Time frame: At enrollment (Baseline, cross-sectional assessment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ege University Faculty of Medicine, Department of Neurology — Izmir

Identifiers

NCT: NCT07193823 · 24-5.1T/1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗