Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00537

2 Trial Registration Date

2016-11-29

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

School of Chinese Medicine, Faculty of Medicine, the Chinese University of Hong Kong

6 Secondary Sponsor

Tuen Mun Hospital

Function

Not Applicable

Please specify

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

i Name

Chan Yu Tat

ii Address

Room 101,1/F, Li Wai Chun Building, Chung Chi College,
The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

iii Phone

+852 60297697

iv Email

augustuschan@cuhk.edu.hk

v Affiliation

School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

LIN Zhixiu

ii Address

Room 101,1/F, Li Wai Chun Building, Chung Chi College,
The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

iii Phone

+852 39436347

iv Email

linzx@cuhk.edu.hk

v Affiliation

School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Randomized Controlled Trial to Assess the Effectiveness and Safety of Acupuncture for Overactive Bladder: A Study in Hong Kong Patient Population

10 Public Title

A Randomized Controlled Trial to Assess the Effectiveness and Safety of Acupuncture for Overactive Bladder

i Public Title in Chinese 研究名稱

針刺治療膀胱過度活躍症的臨床試驗研究

11 Short Title (Optional)

A Clinical Trial to assess the effectiveness and safety of acupuncture for overactive bladder

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?

2016-02-19

iii Full Name of IRB/IEC

New Territories West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

NTWC/CREC/15147

14 Medical Condition Being Studied

Overactive Bladder

15 Intervention

i Types of intervention

Other

Please specify

Traditional Chinese Medicine, Acupuncture

ii Description/ name of Intervention/article

Traditional acupuncture treatment will be applied on the following acupoints: BL32 (Ciliao) (bilateral), BL23 (Shenshu) (bilateral), SP6 (Sanyinjiao) (bilateral), KI3 (Taixi) (bilateral), BL39 (Weiyang) (bilateral), BL28 (Pangguangshu) (bilateral), and CV4 (Guanyuan).

iii Dosage form of the intervention

Acupuncture

iv Dosage of the intervention

A total 16 sessions of acupuncture treatment (twice per week) will be administered to patients in intervention group

v Duration of the intervention

8 weeks

vi Frequency of the intervention

two acupuncture treatment sessions per week

16 Comparative Treatments

i Description/ name of comparative treatments

Sham Acupuncture is a type of acupuncture in which needles of the same size as those of intervention group, however, the needles will not be penetrated into skin; instead, the needles are retracted into needle handle instead of penetrating skin at the same points as the treatment group.
As such subjects will experience a non-penetrating pricking sensation instead of de-qi feeling, characterized as soreness, numbness, heaviness and pressurized feeling.

ii Dosage form of the comparative treatments

Sham acupuncture without penetrating into skin

iii Dosage of the comparative treatments

A total 16 sessions of sham acupuncture treatment (twice per week) will be administered to patients in sham acupuncture group

iv Duration of the comparative treatments

8 weeks

v Frequency of the comparative treatments

two sham acupuncture treatment sessions per week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Both male and female elderly at the age between 60 to 90 years old;

Diagnosed as OAB wet-type (3 or more episodes of incontinence in the past 4 weeks that are no stress-incontinence) according to the diagnosis criteria of the ICS;Physically and mentally able to complete the 7-day voiding diary, Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaire (IIQ7)

Able to give written inform consent (by patients themselves or by caretaker).

ii Exclusion Criteria

OAB symptom caused by stroke or spinal injury

Life threatening infection

Unconsciousness or severe cognition deficits

Dementia caused by Alzheimer’s disease or other neurodegenerative diseases

Undergone incontinence surgery previously

On short-term active diuretic treatment or taking diuretic medication

Had previously received acupuncture treatment for any medical conditions

Patients who are on drug treatment for OAB

Patients who diagnosed as stress urinary incontinence

Pregnancy

Suffering the following diseases: untreated urinary tract infection, urogenital tumors, prostate tumor, benign prostatic hyperplasia, chronic urinary retention

iii Age Minimum

60

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

N/A

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

1) to evaluate the effectiveness of acupuncture treatment for patients with OAB on the reduction of the frequency of incontinence episodes as derived from 7-day voiding diary 2) to evaluate whether acupuncture treatment could improve the subjective symptoms in patients with OAB

20 Anticipated trial start date

2017-03-01

21 Target Sample Size

100 in total, allocation in 1 : 1 ratio. Intervention group (n=50) and Control Group (n=50)

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

7-day voiding diary

ii The metric or method of measurement used

The 7-day voiding diary, which records daily micturitions and symptoms, such as the time of micturition, voided volume per micturition and incontinence episodes in the most recent seven days

iii The timepoint(s) of primary interest

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

24 Secondary Outcome

i The Name of the outcome

Urine NGF level

ii The metric or method of measurement used

Urine NGF level will be detected from the urine of subjects by ELISA kits

iii The timepoint(s) of primary interest

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

Secondary Outcome

i The Name of the outcome

Incontinence Impact Questionnaire (IIQ-7)

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

Secondary Outcome

i The Name of the outcome

Urogenital Distress Inventory (UDI-6)

ii The metric or method of measurement used

Questionnaire

iii The timepoint(s) of primary interest

baseline, the end of treatment (2 months after inclusion) and at the follow-up period (3 months after treatment completion)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-06

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-16010048

28 Date of Registration in Primary Registry

2016-11-29

Back History

Trial Detail