Multiple SclerosisNCT05374031
Multiple Sclerosis Intimacy and Sexuality Questionnaire
An observational study of Multiple Sclerosis and Sexual Dysfunction, run by Bozok University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Sexual Dysfunction, Questionnaires
- What is being tested?
- descriptive study
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2021to 10 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Multiple Sclerosis women
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis, Sexual Dysfunction, Questionnaires
- Being tested
- descriptive study
- Keywords
- Multiple sclerosis, questionnaires, sexual dysfunction, self-report
- Medical subject headings
- Multiple Sclerosis, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
descriptive studyOther
descriptive study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start12 Aug 2021
- Primary completion10 Dec 2021
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hanife dogan, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374031
- Sponsor's protocol ID
- 2017-KAEK 189
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multiple Sclerosis Intimacy and Sexuality Questionnaire-15 (MSISQ-15): Validation of the Turkish Version in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05374031
- Acronym / sponsor ID
- 2017-KAEK 189
- Conditions
- Multiple Sclerosis, Sexual Dysfunction, Questionnaires
- Keywords
- Multiple sclerosis, questionnaires, sexual dysfunction, self-report
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Multiple Sclerosis women
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| descriptive studydescriptive study | Other | – |
Primary outcome
Questionnaire
Time frame: 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.
Questionnaire
Time frame: 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.
Questionnaire
Time frame: 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.
Questionnaire
Time frame: 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.
Questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Sexual Dysfunction, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.