NCT05374031

Brief Summary

Aims: This study aimed to psychometrically evaluate the Turkish version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-15) in women with MS. Methods: The study included 130 women with MS. The Turkish linguistic validation process of the original English MSISQ-15 was performed according to standardized guidelines. Reliability analysis was evaluated with test-retest analysis and intra-class correlation (ICC). Internal consistency between the items was analyzed using the Cronbach's alpha coefficient. Item analysis results were used to assess the contribution of the items to the scale. In evaluating the validity of the scale, the relationship between the MSISQ and the Female Sexual Function Index (FSFI), the Multiple Sclerosis Quality of Life Questionnaire-54 (MSQOL-54), and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PSIQ-12) was investigated. Psychometric properties were analyzed using internal consistency, test-rest reliability, construct validity, and floor-ceiling effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 2, 2022

Last Update Submit

May 11, 2022

Conditions

Keywords

Multiple sclerosisquestionnairessexual dysfunctionself-report

Outcome Measures

Primary Outcomes (5)

  • Questionnaire

    Multiple Sclerosis Intimacy and Sexuality Scale is a 15-item self-report measure that assesses the impact of MS symptoms on sexual activity and satisfaction over the past 6 months.Higher scores indicate greater sexual problems.

    day 1

  • Questionnaire

    Female Sexual Function Index is a 19-item scale that evaluates the sexual functions of female patients. The questionnaire consists of 6 separate subdimensions: desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.

    day 1

  • Questionnaire

    Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire is an instrument that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse. Increasing scores indicate better sexual function.

    day 1

  • Questionnaire

    Global Pelvic Floor Bother Questionnaire is used to evaluate the presence and severity of the most common clinical problems caused by the pelvic floor dysfunction, namely, stress urinary incontinence, frequent and sudden urination sensation, urge incontinence, voiding difficulty, pelvic organ prolapse, obstructive defecation, fecal incontinence, and dyspareunia. A high score indicates more pelvic floor symptom complaints.

    day 1

  • Questionnaire

    Multiple Sclerosis Quality of Life Questionnaire-54 is used to evaluate the quality of life of patients with MS. Higher scores indicate better quality of life.

    day 1

Interventions

descriptive study

Eligibility Criteria

Age19 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Multiple Sclerosis women

You may qualify if:

  • Women over the age of 18 who were literate,
  • who did not have any mental problems preventing cooperation and understanding,
  • who were diagnosed with MS

You may not qualify if:

  • Having pelvic organ prolapse stage 2 or more;
  • having a history of relapse in the past 30 days;
  • experiencing loss of balance or gait disturbance caused by a condition other than MS;
  • being pregnant; having a history of gynecological, urological and/or neurological surgery;
  • having a history of cesarean or vaginal birth in the past six months;
  • being sexually inactive; and, having urinary tract infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University

Yozgat, 66000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 13, 2022

Study Start

August 12, 2021

Primary Completion

December 10, 2021

Study Completion

March 10, 2022

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations