Translation and Validation of MESA Questionnaire of Chinese Language Version

NCT03803878 | Unknown

• 1 other identifier: 2018-162-KY
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  baseline

• The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.

  baseline

• The test-retest reliability of MESA questionnaire

  screening and baseline periods

• The responsiveness of MESA questionnaire

  baseline, week 12

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The questionnaire validation is targeted at women with urgency-predominant mixed urinary incontinence.

You may qualify if:

• Female patients diagnosed with MUI in accordance with EAU guideline by history taking, physical examination, laboratory tests and specialist diagnosis;
• Age between 18 and 80 years old;
• At least 4 episodes of UUI in 3-day voiding diary;
• 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;
• Positive cough test;

You may not qualify if:

• Having pure SUI, pure UUI, overflow UI or neurogenic bladder;
• Uncontrolled urinary tract infection;
• Tumor in urinary system or pelvic organs;
• Pelvic organ prolapse≥degreeⅡ;
• Residual urine volume≥100ml;
• Maximum flow rate\<15ml/s;
• In the past 1 month, receiving treatment of acupuncture or positive medications targeted at incontinence, such as antimuscarinic drugs;
• Underwent anti-incontinence or pelvic organ surgery, including metrectomy;
• Complication of severe diabetes or hypertension;
• 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;
• Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology and coagulation function, or obvious cognitive disability;
• Installed a cardiac pacemaker;
• Allergic to Solifenacin or with contraindications to antimuscarinic drug, including urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis, ulcerative colitis and angle-closure glaucoma;
• Allergic to metal or intolerant to the stimulation of electroacupuncture;
• Pregnant or plan to conceive in the future 1 year, or delivery in the past one year.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang An Men Hospital

Beijing, 100053, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31689809 DERIVED

Study Officials

• Zhishun Liu, PhD

  Guang An Men Hospital

  STUDY CHAIR

Central Study Contacts

Zhishun Liu, PhD

CONTACT

86-010-88002331; zhishunjournal@163.com

Yuanjie Sun, Master

CONTACT

86-010-18810337542; puzhisun@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: March 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

CN (1)