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SF-QUALIVEEN Turkish Validity and Reliability Study

SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04483609
Enrollment
63
Registered
2020-07-23
Start date
2020-07-30
Completion date
2020-10-30
Last updated
2021-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, urological dysfunction, assessment, scale

Brief 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. 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.

Interventions

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.

OTHERQuestionnaire administration validation and reliability

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.

Sponsors

Istanbul Aydın University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. age 18-65; 2. definitive diagnosis of MS according to McDonald criteria; 3. ability to read and write in Turkish.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
SF-Qualiveen scoreBaselineTo evaluate the impact of urological problems on quality of life

Secondary

MeasureTime frameDescription
Urogenital Distress Inventory (UDI-6)BaselineTo assess problems caused by urinary symptoms

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026