Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00499

2 Trial Registration Date

2016-01-11

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

Lee Lai Loi

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

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Chan Symphorosa Shing Chee

ii Address

1E, Department of Obstetrics and Gynaecology, Prince of Wales Hospital, Shatin, N.T., HONG KONG

iii Phone

35052814

iv Email

symphorosa@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Acupuncture for urinary incontinence in Chinese women: a randomized controlled trial

10 Public Title

Acupuncture for urinary incontinence in Chinese women: a randomized controlled trial

i Public Title in Chinese 研究名稱

針灸用於處理華人婦女小便失禁問題之隨機研究

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?

2015-12-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.510-T

14 Medical Condition Being Studied

urinary incontinence

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

a) acupuncture and b)pelvic floor exercise

iii Dosage form of the intervention

a) acupuncture; b) pelvic floor exercise (pelvic floor muscle contraction)

iv Dosage of the intervention

a) 6 visits; b) 10 contractions per set

v Duration of the intervention

a) 30 minutes per visit; b) 10 seconds per contraction

vi Frequency of the intervention

a) once a week; b) 3 sets per day

16 Comparative Treatments

i Description/ name of comparative treatments

Pelvic floor exercise

ii Dosage form of the comparative treatments

Pelvic floor muscle contraction

iii Dosage of the comparative treatments

10 contractions per set

iv Duration of the comparative treatments

10 seconds per contraction

v Frequency of the comparative treatments

3 sets per day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

All women presented to the Urogynaecology clinic for urinary incontinence; and who are diagnosed kidney asthenia after the assessment by the Traditional Chinese Medicine Practitioner.

ii Exclusion Criteria

Exclusion criteria include women in pregnancy or plan to be pregnant within the study period, allergy to metal, uncontrolled diabetes mellitus or uncontrolled hypertension and cardiovascular diseases, history of pelvic floor injury, pelvic radiation or who currently have pelvic organ prolapse that may affect the urinary incontinence symptoms, mental incapacity that would preclude completion of the questionnaire, diagnosis other than kidney asthenia by a registered Traditional Chinese Medicine practitioner and those who refuse to join.

iii Age Minimum

18

iv Age Maximum

N/A

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Concealed randomization was performed with 1:1 ratio by computer generated random number series.

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

The objective of this study is to evaluate the effectiveness of acupuncture on urinary incontinence and quality of life in Hong Kong Chinese women.

20 Anticipated trial start date

2016-01-15

21 Target Sample Size

170

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Subjective outcome of the urinary incontinence at 12 week

ii The metric or method of measurement used

Subjective outcome on their urinary incontinence as “much better”, “better”, “same”, “worse” or “much worse” are asked.

iii The timepoint(s) of primary interest

at 12 week

Primary Outcome

i The Name of the outcome

Subjective outcome of the urinary incontinence at 24 week

ii The metric or method of measurement used

Subjective outcome on their urinary incontinence as “much better”, “better”, “same”, “worse” or “much worse” are asked.

iii The timepoint(s) of primary interest

at 24 week

24 Secondary Outcome

i The Name of the outcome

UDI-6 and IIQ-7 scores

ii The metric or method of measurement used

Self-answer questionniare will be completed and scores will be calculated.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

Secondary Outcome

i The Name of the outcome

VAS score

ii The metric or method of measurement used

Visual analog scale questionnaire will be completed and score will be measured.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

Secondary Outcome

i The Name of the outcome

Mean number of incontinence episodes over 24 hours

ii The metric or method of measurement used

Urinary diary will be completed and data of number of incontinence episodes will be collected.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

Secondary Outcome

i The Name of the outcome

Severity of incontinence episodes

ii The metric or method of measurement used

Urinary diary will be completed and data of severity of incontinence episodes will be collected.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

Secondary Outcome

i The Name of the outcome

Complications of acupuncture

ii The metric or method of measurement used

Adverse event will be asked.

iii The timepoint(s) of primary interest

during acupuncture treatment session

Secondary Outcome

i The Name of the outcome

Compliance of pelvic floor exercise

ii The metric or method of measurement used

Pelvic floor exercise log will be completed by subjects, and compliance will be investigated.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

Secondary Outcome

i The Name of the outcome

Need for medical treatment or surgical treatment for urinary incontinence

ii The metric or method of measurement used

Subject will be followed-up and any medical treatment or surgical treatment will be recorded.

iii The timepoint(s) of primary interest

at 6, 12, 18, 24, 30, 36, 42 ,48 week

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-05-07

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-16007766

28 Date of Registration in Primary Registry

2016-01-11

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Trial History Detail on 2017-05-04