Clinical trial NCT03803878: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Questionnaire
Mixed Urinary Incontinence
Urgency-predominant Mixed Urinary Incontinence
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The questionnaire validation is targeted at 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.

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.

Primary outcomes:
measure: The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.
timeFrame: screening and baseline periods
Secondary outcomes:
measure: 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.
timeFrame: baseline
measure: The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.
timeFrame: baseline
measure: The test-retest reliability of MESA questionnaire
timeFrame: screening and baseline periods
measure: The responsiveness of MESA questionnaire
timeFrame: baseline, week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang An Men Hospital
Study officials:
affiliation: Guang An Men Hospital
name: Zhishun Liu, PhD
role: STUDY_CHAIR
References:
citation: 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.