QuestionnaireNCT03803878
Translation and Validation of MESA Questionnaire of Chinese Language Version
An observational study of Questionnaire and Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Questionnaire, Mixed Urinary Incontinence, Urgency-predominant Mixed Urinary Incontinence
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The questionnaire validation is targeted at women with urgency-predominant mixed urinary incontinence.
Who may be able to join
- 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;
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang An Men Hospital
Beijing, 100053
Yuanjie Sun, Master, 8610-010-88002331, puzhisun@163.com
About this study
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
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).
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: baseline
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.
Measured: baseline
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.
Measured: screening and baseline periods
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.
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Mar 2019
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for QuestionnaireStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, PhD, Study chair, Guang An Men Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803878
- Sponsor's protocol ID
- 2018-162-KY
- Status last verified
- Sep 2020
- First submitted
- 11 Jan 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31689809
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03803878
- Acronym / sponsor ID
- 2018-162-KY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The questionnaire validation is targeted at women with urgency-predominant mixed urinary incontinence.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
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
The test-retest reliability of MESA questionnaire
Time frame: screening and baseline periods
The responsiveness of MESA questionnaire
Time frame: baseline, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 31689809Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, PhD study chair
Guang An Men Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Questionnaire and Mixed Urinary Incontinence, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu, PhD (86-010-88002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI. (time frame: screening and baseline periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.