Skip to main content
OpenTrials
Completed

NCT Number: NCT04483609

SF-QUALIVEEN Turkish 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Üniversitesi-Cerrahpaşa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. SF-Qualiveen score

    Time frame: Baseline

    To evaluate the impact of urological problems on quality of life

Secondary outcomes

  1. Urogenital Distress Inventory (UDI-6)

    Time frame: Baseline

    To assess problems caused by urinary symptoms

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2020
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.