SF-QUALIVEEN Turkish Validity and Reliability Study

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Questionnaire administration validation and reliability; Other: Questionnaire administration pre test

• Registration Number: NCT04483609
• Lead Sponsor: Istanbul Aydın University

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.

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-23
• Study Start: 2020-07-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Validation and Reliability Group	Questionnaire administration validation and reliability	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.
pre-test Group	Questionnaire administration pre test	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.

Primary Outcome Measures

Name	Time	Method
SF-Qualiveen score	Baseline	To evaluate the impact of urological problems on quality of life

Secondary Outcome Measures

Name	Time	Method
Urogenital Distress Inventory (UDI-6)	Baseline	To assess problems caused by urinary symptoms

Trial Locations

Locations (1)

İstanbul Üniversitesi-Cerrahpaşa; 🇹🇷 İstanbul, Turkey