Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Translation and Validation of MESA Questionnaire of Chinese Language Version

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803878
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date January 11, 2019
First Posted Date January 15, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date March 1, 2019
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2020)
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.
Original Primary Outcome Measures
 (submitted: January 11, 2019)
The construct validity of MESA questionnaire compared with 3-day voiding diary in deciding urgency-predominant MUI. [ Time Frame: week 0 ]
In 3-day voiding diary, the type and episodes of incontinence are all recorded.
Change History
Current Secondary Outcome Measures
 (submitted: August 30, 2020)
  • 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.
Original Secondary Outcome Measures
 (submitted: January 11, 2019)
  • The construct 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 construct 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: week 0 and baseline ]
    The test-retest reliability of MESA will be evaluated at the screening and baseline period with about one-week interval among women with urgency-predominant mixed urinary incontinence.
  • The responsibility of MESA questionnaire [ Time Frame: baseline, week 12 ]
    The responsibility of MESA questionnaire will be evaluated before and after the treatment among women with urgency-predominant mixed urinary incontinence.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Translation and Validation of MESA Questionnaire of Chinese Language Version
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
Brief Summary

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).

Detailed Description

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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The questionnaire validation is targeted at women with urgency-predominant mixed urinary incontinence.
Condition
  • Questionnaire
  • Mixed Urinary Incontinence
  • Urgency-predominant Mixed Urinary Incontinence
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
    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
    Group 2 is anticipated to consist of 282 women with urgency-predominant MUI.
  • Group 3
    Group 3 is anticipated to consist of 94 women with urgency-predominant MUI.
Publications * Sun Y, Liu Y, Su T, Yuan J, Liu Z. Medical, epidemiologic, and social aspects of aging urinary incontinence questionnaire: Study protocol for the translation and validation of a Chinese language version. Medicine (Baltimore). 2019 Nov;98(44):e17719. doi: 10.1097/MD.0000000000017719.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 18, 2019)
300
Original Estimated Enrollment
 (submitted: January 11, 2019)
350
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  1. Female patients diagnosed with MUI in accordance with EAU guideline by history taking, physical examination, laboratory tests and specialist diagnosis;
  2. Age between 18 and 80 years old;
  3. At least 4 episodes of UUI in 3-day voiding diary;
  4. With MUI for at least 3 months, and urgency urinary incontinence dominates more than 50% of the total incontinence episodes in 3-day voiding diary;
  5. Positive cough test;
  6. A voluntarily-signed written informed content. For patients in group 1, inclusion criteria of 1), 2), 5) and 6) are required to meet. Those also meeting the criteria of 3) and 4) will enter group 2 at the same time.

For patients in group 2 and groups 3, all inclusion criteria are required to meet.

Exclusion criteria

  1. Having pure SUI, pure UUI, overflow UI or neurogenic bladder;
  2. Uncontrolled urinary tract infection;
  3. Tumor in urinary system or pelvic organs;
  4. Pelvic organ prolapse≥degreeⅡ;
  5. Residual urine volume≥100ml;
  6. Maximum flow rate<15ml/s;
  7. In the past 1 month, receiving treatment of acupuncture or positive medications targeted at incontinence, such as antimuscarinic drugs;
  8. Underwent anti-incontinence or pelvic organ surgery, including metrectomy;
  9. Complication of severe diabetes or hypertension;
  10. Complication of diseases in nervous system that could hamper hypourethral function, such as multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury, cauda equina nerve injury and multiple system atrophy;
  11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
  12. Installed a cardiac pacemaker;
  13. Allergic to Solifenacin or with contraindications to antimuscarinic drug, including urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis and angle-closure glaucoma;
  14. Allergic to metal or intolerant to the stimulation of electroacupuncture;
  15. Pregnant or plan to conceive in the future 1 year, or delivery in the past one year.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zhishun Liu, PhD 86-010-88002331 zhishunjournal@163.com
Contact: Yuanjie Sun, Master 86-010-18810337542 puzhisun@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803878
Other Study ID Numbers 2018-162-KY
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators Not Provided
Investigators
Study Chair: Zhishun Liu, PhD Guang An Men Hospital
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date September 2020