Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00585

2 Trial Registration Date

2018-02-12

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Tse Wan Ying

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Wan Ying Tse

ii Address

Fanling Family Medicine Centre, 1/F, Fanling Health Centre, 2 Pik Fung Road, Fanling, New Territories

iii Phone

26394601

iv Email

twy702a@ha.org.hk

v Affiliation

Hospital Authority

vi Country

Hong Kong

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

i Name

Wan Ying Tse

ii Address

Fanling Family Medicine Centre, 1/F, Fanling Health Centre, 2 Pik Fung Road, Fanling, New Territories

iii Phone

26394601

iv Email

twy702a@ha.org.hk

v Affiliation

Family Medicine Centre, Department of Family Medicine, NTEC, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

Prevalence of Urinary Incontinence in Chinese Elderly Male in Primary Care Setting and their Quality of Life in Hong Kong

10 Public Title

Prevalence of Urinary Incontinence in Chinese Elderly Male in Primary Care Setting and their Quality of Life in Hong Kong

i Public Title in Chinese 研究名稱

65歲或以上中國男士尿失禁在基層醫療的患病率以及其生活質量

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?

2017-12-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.655

14 Medical Condition Being Studied

Urinary Incontinence

15 Intervention

i Types of intervention

Other

Please specify

Nil

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

Male

65 years old or above

Chinese ethnicity

ii Exclusion Criteria

Female

non-Chinese ethnicity

under 65 years old

patients unable to give consent

iii Age Minimum

65

iv Age Maximum

999

v Gender

Male

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)

The aim of this study is to find out the prevalence of urinary incontinence in elderly male patients in primary care setting and to assess how this problem affects their quality of life.

20 Anticipated trial start date

2018-03-01

21 Target Sample Size

330

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Prevalence of Urinary Incontinence

ii The metric or method of measurement used

International Cosultation on Incontinence Questionnaire Short Form

iii The timepoint(s) of primary interest

N/A

24 Secondary Outcome

i The Name of the outcome

Quality of life

ii The metric or method of measurement used

King's health questionnaire

iii The timepoint(s) of primary interest

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-03-22

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-02-12