Multiple SclerosisNCT04483609
SF-QUALIVEEN Turkish Validity and Reliability Study
An observational study of Multiple Sclerosis, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a significant deterioration in the quality of life of people with MS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Questionnaire administration pre test and Questionnaire administration validation and reliability
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2020to 30 Oct 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pre-test: 10 patients with multiple sclerosis will be evaluated.Inclusion and exlusion criteria listed above. Validation and reliability: 70 patients with multiple sclerosis will be evaluated.Inclusion and exlusion criteria listed above.
Who may be able to join
- age 18-65;
- definitive diagnosis of MS according to McDonald criteria;
- ability to read and write in Turkish.
Who cannot join
- acute attacks of MS (within 3 months);
- cognitive impairment (Mini Mental test result 24 points and below);
- any chronic disease other than MS;
- active malignant tumors;
- symptomatic urinary tract infections;
- patients who changed treatment within the test-retest period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study
Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a significant deterioration in the quality of life of people with MS. In chronic diseases such as MS, patients experiences need to be measured directly in order to have information about patients perceptions about the effect of the disease on quality of life. However, there are a small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated scale for patients with MS who assess the urinary-specific quality of life by examining the impact of a wide range of bladder problems.The aim of our study is to make the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale.
Read the detailed description
The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Questionnaire administration pre test, Questionnaire administration validation and reliability
- Keywords
- multiple sclerosis, urological dysfunction, assessment, scale
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administration pre testOther
After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.
Questionnaire administration validation and reliabilityOther
After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.
| Study group | Role | What they receive |
|---|---|---|
| pre-test Group | 10 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period. Receives: Other: Questionnaire administration pre test | |
| Validation and Reliability Group | 80 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period. Receives: Other: Questionnaire administration validation and reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-Qualiveen score
To evaluate the impact of urological problems on quality of life
Measured: Baseline
Secondary outcomes (1)
Urogenital Distress Inventory (UDI-6)
To assess problems caused by urinary symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start30 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
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
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur OVACIK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483609
- Sponsor's protocol ID
- 2018/23-21
- Status last verified
- Jun 2021
- First submitted
- 21 Jul 2020
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT04483609
- Acronym / sponsor ID
- 2018/23-21
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, urological dysfunction, assessment, scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 23 Jul 2020 (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.
Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a significant deterioration in the quality of life of people with MS. In chronic diseases such as MS, patients experiences need to be measured directly in order to have information about patients perceptions about the effect of the disease on quality of life. However, there are a small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated scale for patients with MS who assess the urinary-specific quality of life by examining the impact of a wide range of bladder problems.The aim of our study is to make the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale.
Detailed description
The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients with multiple sclerosis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-test Group | – | Other: Questionnaire administration pre test10 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period. |
| Validation and Reliability Group | – | Other: Questionnaire administration validation and reliability80 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-test: 10 patients with multiple sclerosis will be evaluated.Inclusion and exlusion criteria listed above. Validation and reliability: 70 patients with multiple sclerosis will be evaluated.Inclusion and exlusion criteria listed above.
Key inclusion criteria (3 listed)
- age 18-65;
- definitive diagnosis of MS according to McDonald criteria;
- ability to read and write in Turkish.
Key exclusion criteria (6 listed)
- acute attacks of MS (within 3 months);
- cognitive impairment (Mini Mental test result 24 points and below);
- any chronic disease other than MS;
- active malignant tumors;
- symptomatic urinary tract infections;
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 |
|---|---|---|
| Questionnaire administration pre testAfter the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis. | Other | pre-test Group |
| Questionnaire administration validation and reliabilityAfter the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again. | Other | Validation and Reliability Group |
Primary outcome
SF-Qualiveen score
Time frame: Baseline
To evaluate the impact of urological problems on quality of life
1 secondary outcome
Urogenital Distress Inventory (UDI-6)
Time frame: Baseline
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 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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, run by Istanbul Aydın 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 18 Jun 2021. 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?
SF-Qualiveen score (time frame: Baseline). 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 18 Jun 2021.