SF-QUALIVEEN Turkish Validity and Reliability Study

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Questionnaire administration pre test; Other: Questionnaire administration validation and reliability

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • İstanbul Üniversitesi-Cerrahpaşa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaire administration pre test; 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.
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.	Other: Questionnaire 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-Qualiveen score	To evaluate the impact of urological problems on quality of life	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urogenital Distress Inventory (UDI-6)	To assess problems caused by urinary symptoms	Baseline

Collaborators and Investigators

• Sponsor: Istanbul Aydın University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: multiple sclerosis; assessment; urological dysfunction; scale
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2018/23-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No