Translation and Validation of MESA Questionnaire of Chinese Language Version

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Urgency-predominant Mixed Urinary Incontinence; Questionnaire; Mixed Urinary Incontinence

Study type: Observational

Funder types: Other

Identifiers

NCT03803878

2018-162-KY

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

300 participants in 3 patient groups

Group 1

Description:

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

Description:

Group 2 is anticipated to consist of 282 women with urgency-predominant MUI.

Group 3

Description:

Group 3 is anticipated to consist of 94 women with urgency-predominant MUI.