Translation and Validation of MESA Questionnaire of Chinese Language Version

Questionnaire Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803878
• Other study ID #: 2018-162-KY
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Zhishun Liu, PhD
• Phone: 86-010-88002331
• Email: zhishunjournal[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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=degree?;

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.

Related Conditions & MeSH terms

• Enuresis
• Mixed Urinary Incontinence
• Questionnaire
• Urgency-predominant Mixed Urinary Incontinence
• Urinary Incontinence

Locations

Country	Name	City	State
China	Guang An Men Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.	The extended clinical evaluation mainly includes physical examination, 3-day voiding diary, cough stress teat, urinalysis and residual urine volume by ultrasonography.	screening and baseline periods
Secondary	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.	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.	baseline
Secondary	The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.	In 3-day voiding diary, the type and episodes of incontinence are all recorded.	baseline
Secondary	The test-retest reliability of MESA questionnaire	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.	screening and baseline periods
Secondary	The responsiveness of MESA questionnaire	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.	baseline, week 12