CCRB Logo

Trial Detail

CUHK_CCRB00537

2016-11-29

Prospective

N/A

Health and Medical Research Fund

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

Tuen Mun Hospital

Not Applicable

Chan Yu Tat

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

+852 60297697

augustuschan@cuhk.edu.hk

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

Hong Kong

LIN Zhixiu

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

+852 39436347

linzx@cuhk.edu.hk

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

Hong Kong

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

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

針刺治療膀胱過度活躍症的臨床試驗研究

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

Hong Kong

Yes

2016-02-19

New Territories West Cluster Research Ethics Committee

NTWC/CREC/15147

Overactive Bladder

Other

Traditional Chinese Medicine, Acupuncture

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).

Acupuncture

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

8 weeks

two acupuncture treatment sessions per week

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.

Sham acupuncture without penetrating into skin

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

8 weeks

two sham acupuncture treatment sessions per week

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).

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

60

90

Both Male and Female

Interventional

Randomized

N/A

Placebo

Double-blind

Parallel

3

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

2017-03-01

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

Recruiting

7-day voiding diary

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

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

Urine NGF level

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

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

Incontinence Impact Questionnaire (IIQ-7)

Questionnaire

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

Urogenital Distress Inventory (UDI-6)

Questionnaire

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

No

2017-04-06

ChiCTR-INR-16010048

2016-11-29

Type Document Published On  
No documents yet.
  • Page 1 of 1.