Translation and Validation of MESA Questionnaire of Chinese Language Version
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|ClinicalTrials.gov Identifier: NCT03803878|
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : September 16, 2020
The study is to translate the Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire into a Chinese language version and test the reliability and validity among women with urgency-predominant mixed urinary incontinence.
The hypothesis is that the Chinese language version of the MESA questionnaire will have adequate measurement properties (e.g. reliability and validity).
|Condition or disease|
|Questionnaire Mixed Urinary Incontinence Urgency-predominant Mixed Urinary Incontinence|
Mixed urinary incontinence(MUI) is regarded as urgency-predominant when urgency incontinence episodes dominate over stress incontinence episodes, and vice versa. The treatment of MUI often begins with the most bothersome symptoms.
MESA questionnaire is a reliable and validated tool to evaluate the severity and predominance of stress or urgency urinary incontinence. At present, it hasn't been translated into a Chinese language version and validated.
The validation study of MESA questionnaire is embedded in a randomized controlled trial conducted among female patients, of which the data will be collected and analysed.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Medical, Epidemiologic, and Social Aspects of Aging (MESA) Urinary Incontinence Questionnaire: Translation and Validation of the Chinese Language Version in Women With Urgency-predominant Mixed Urinary Incontinence|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Group 1 is anticipated to consist of 300 women with MUI, and the categorization function of MESA questionnaire will be validated among those patients.
Group 2 is anticipated to consist of 282 women with urgency-predominant MUI.
Group 3 is anticipated to consist of 94 women with urgency-predominant MUI.
- The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI. [ Time Frame: screening and baseline periods ]The extended clinical evaluation mainly includes physical examination, 3-day voiding diary, cough stress teat, urinalysis and residual urine volume by ultrasonography.
- The criteria validity of MESA questionnaire compared with International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) in severity assessing among women with urgency-predominant mixed urinary incontinence. [ Time Frame: baseline ]ICIQ SF is a validated questionnaire to evaluate both the severity of incontinence symptoms and influence on QoL in the past four weeks. The questionnaire is consisted of four items, including frequency, leakage amount, impact on QoL and the cause of urinary incontinence. The total score of the ICIQ SF ranges from 0 to 21, with a higher score indicating worse symptoms and QoL.
- The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence. [ Time Frame: baseline ]In 3-day voiding diary, the type and episodes of incontinence are all recorded.
- The test-retest reliability of MESA questionnaire [ Time Frame: screening and baseline periods ]The test-retest reliability of MESA will be evaluated at the screening and baseline period with about one- to two-week interval among women with urgency-predominant mixed urinary incontinence.
- The responsiveness of MESA questionnaire [ Time Frame: baseline, week 12 ]The responsiveness of MESA questionnaire will be evaluated before and after the treatment among women with urgency-predominant mixed urinary incontinence compared with 3-day voiding diary and ICIQ SF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803878
|Contact: Zhishun Liu, PhDfirstname.lastname@example.org|
|Contact: Yuanjie Sun, Masteremail@example.com|
|Guang An Men Hospital||Recruiting|
|Beijing, China, 100053|
|Contact: Yuanjie Sun, Master 8610-010-88002331 firstname.lastname@example.org|
|Study Chair:||Zhishun Liu, PhD||Guang An Men Hospital|