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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 15, 2020
Sponsor:
Information provided by (Responsible Party):
Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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).


Condition or disease
Questionnaire Mixed Urinary Incontinence Urgency-predominant Mixed Urinary Incontinence

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The questionnaire validation is targeted at women with urgency-predominant mixed urinary incontinence.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhishun Liu, PhD 86-010-88002331 zhishunjournal@163.com
Contact: Yuanjie Sun, Master 86-010-18810337542 puzhisun@163.com

Locations
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China
Guang An Men Hospital Recruiting
Beijing, China, 100053
Contact: Yuanjie Sun, Master    8610-010-88002331    puzhisun@163.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Chair: Zhishun Liu, PhD Guang An Men Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liu Zhishun, Principle investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03803878    
Other Study ID Numbers: 2018-162-KY
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders