Multiple Sclerosis Intimacy and Sexuality Questionnaire

Multiple Sclerosis Clinical Trial

Official title:

The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374031
• Other study ID #: 2017-KAEK 189
• Status: Completed
• Start date: August 12, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: May 2022
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Sexual Dysfunction

Intervention

Other:
• descriptive study
descriptive study

Locations

Country	Name	City	State
Turkey	Yozgat Bozok University	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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