Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00651

2 Trial Registration Date

2018-12-28

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Department of Obstetrics and Gynaecology

5 Primary Sponsor

Department of Obstetrics and Gynaecology

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

LAI LOI LEE

ii Address

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

85235052583

iv Email

loretalee@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

LAI LOI LEE

ii Address

1E, Department of Obstetrics and Gynaecology,
Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

35052583

iv Email

loretalee@cuhk.edu.hk

v Affiliation

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Validation Study of the Traditional Chinese Version of ICIQ-UI Short Form (ICIQ-UI SF)

10 Public Title

Validation Study of the Traditional Chinese Version of ICIQ-UI Short Form (ICIQ-UI SF)

i Public Title in Chinese 研究名稱

ICIQ-UI Short Form (ICIQ-UI SF) 繁體中文版之確認研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-12-12

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.531

14 Medical Condition Being Studied

Incontinence

15 Intervention

i Types of intervention

Other

Please specify

N/A

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Women attending the Gynaecology clinics (PWH and AHNH) with urinary incontinence

ii Exclusion Criteria

Patient age less than 18 years

Patient who would preclude completion of the questionnaire e.g. mental incapacity

Patient who are illiterate

Patients refuse to participate in the study

iii Age Minimum

18

iv Age Maximum

999

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-01-03

21 Target Sample Size

80

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Reliability (Internal consistency) of ICIQ-UI SF

ii The metric or method of measurement used

The reliability of the scales will be assessed by item-total correlations and Cronbach’s alpha coefficient.

iii The timepoint(s) of primary interest

The time when the questionnaire is answered.

Primary Outcome

i The Name of the outcome

Test-retest reliability of ICIQ-UI SF

ii The metric or method of measurement used

The test-retest reliability will be assessed by Intraclass Correlation Coefficient (ICC).

iii The timepoint(s) of primary interest

The time when the questionnaire is answered. E.g. pre-treatment and post treatment.

Primary Outcome

i The Name of the outcome

Convergent validity of ICIQ-UI SF

ii The metric or method of measurement used

The convergent validity of the ICIQ is estimated by Pearson’s correlation with the UDI-6 and IIQ-7, as this will assess how close ICIQ-UI SF is related to other measures, UDI-6 and IIQ-7, of the same construct.

iii The timepoint(s) of primary interest

The time when the questionnaire is answered.

Primary Outcome

i The Name of the outcome

Criterion validity of ICIQ-UI SF

ii The metric or method of measurement used

Criterion validity is established by comparing the ICIQ-UI SF with objective data of symptom severity and clinical diagnoses.

iii The timepoint(s) of primary interest

The time when the questionnaire is answered.

Primary Outcome

i The Name of the outcome

Responsiveness of ICIQ-UI SF

ii The metric or method of measurement used

The pre- and post-treatment scores will be compared by paired t-tests.

iii The timepoint(s) of primary interest

The time when the questionnaire is answered.

24 Secondary Outcome

i The Name of the outcome

The score of ICIQ-UI SF

ii The metric or method of measurement used

Sum up of score of ICIQ-UI SF (Tradtional version) questionnaire.

iii The timepoint(s) of primary interest

The time when the questionnaire is answered.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2024-05-16

27 Primary Registry and Trial Identifying Number

ChiCTR1900021048

28 Date of Registration in Primary Registry

2018-12-28

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Trial History Detail on 2019-07-09