SF-QUALIVEEN Turkish Validity and Reliability Study

NCT04483609 | Completed

• 1 other identifier: 2018/23-21
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; urological dysfunction; assessment; scale

Outcome Measures

Primary Outcomes (1)

• SF-Qualiveen score

  To evaluate the impact of urological problems on quality of life

  Baseline

Secondary Outcomes (1)

• Urogenital Distress Inventory (UDI-6)

  Baseline

Study Arms (2)

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

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

Interventions

Questionnaire administration pre test OTHER

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.

pre-test Group

Questionnaire administration validation and reliability OTHER

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.

Validation and Reliability Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: July 30, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

TU (1)