Multiple Sclerosis Intimacy and Sexuality Questionnaire

Sponsor
Bozok University (Other)
Overall Status
Completed
CT.gov ID
NCT05374031
Collaborator
(none)
130
1
6.9
18.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: descriptive study

Study Design

Study Type:
Observational
Actual Enrollment :
130 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis
Actual Study Start Date :
Aug 12, 2021
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Mar 10, 2022

Outcome Measures

Primary Outcome Measures

  1. Questionnaire [day 1]

    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.

  2. Questionnaire [day 1]

    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.

  3. Questionnaire [day 1]

    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.

  4. Questionnaire [day 1]

    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.

  5. Questionnaire [day 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 64 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yozgat Bozok University Yozgat Turkey 66000

Sponsors and Collaborators

  • Bozok University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
hanife dogan, Assistant Professor, Bozok University
ClinicalTrials.gov Identifier:
NCT05374031
Other Study ID Numbers:
  • 2017-KAEK 189
First Posted:
May 13, 2022
Last Update Posted:
May 13, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by hanife dogan, Assistant Professor, Bozok University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022