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Trial History Detail on 2016-04-05

CUHK_CCRB00499

2016-01-11

Prospective

N/A

Department of Obstetrics and Gynaecology

Department of Obstetrics and Gynaecology

N/A

Not Applicable

Lee Lai Loi

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

26326250

loretalee@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Chan Symphorosa Shing Chee

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

26322814

symphorosa@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

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

針灸用於處理華人婦女小便失禁問題之隨機研究

Hong Kong

Yes

2015-12-22

Joint CUHK-NTEC Clinical Research Ethics Committee

2015.510-T

urinary incontinence

Procedure

a) acupuncture and b)pelvic floor exercise

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

a) 6 visits; b) 10 contractions per set

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

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

Pelvic floor exercise

Pelvic floor muscle contraction

10 contractions per set

10 seconds per contraction

3 sets per day

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.

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.

18

N/A

Female

Interventional

Randomized

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

Active

Single-blind

Investigator/research team

Parallel

2

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

2016-01-15

170

Not Yet Recruiting

Subjective outcome of the urinary incontinence at 12 week

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

at 12 week

Subjective outcome of the urinary incontinence at 24 week

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

at 24 week

UDI-6 and IIQ-7 scores

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

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

VAS score

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

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

Mean number of incontinence episodes over 24 hours

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

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

Severity of incontinence episodes

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

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

Complications of acupuncture

Adverse event will be asked.

during acupuncture treatment session

Compliance of pelvic floor exercise

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

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

Need for medical treatment or surgical treatment for urinary incontinence

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

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

No

2018-05-07

ChiCTR-INR-16007766

2016-01-11

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