Acupuncture on Post-Stroke Overactive Bladder

NCT ID: NCT02568774

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-08-31

Brief Summary

This study evaluates the effect of acupuncture on post-stroke overactive bladder symptoms. Participants will be put into groups randomly and compared. There are two groups: traditional acupuncture and usual care. The ratio of group allocation is 1:1.

Detailed Description

Current practice in management of OAB is quite limited. Acupuncture, which is a major treatment modality of traditional Chinese medicine, has also claimed to have favourable therapeutic effect on OAB. Previous study found that acupuncture at the BL-33 point was effective for controlling the overactive bladder. Although acupuncture has been shown to be effective in treating OAB, there has been no randomized controlled trial examining the efficacy of acupuncture on patients with post-stroke. Given the high incidence of OAB in post-stroke patients, potentially effective alternative treatments should be investigated.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Acupuncture

Acupoints which are empirical for treating OAB in terms of Traditional Chinese medicine theory are used (in the sequence of scalp reproduction area and motor area of the unaffected side, RN3, bilateral BL32, BL33, BL28, BL39). And Ear point urinary bladder, and Ear point uterus will be treated after removal of needles. Needles will be left for 30 minutes and then removed. Subjects will be treated with acupuncture 2 times per week for the first 2 weeks and 1 per week for the 3rd and 4th week.

Group Type: EXPERIMENTAL

Traditional Acupuncture

Intervention Type: OTHER

Treatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner.

Usual Care

Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.

Interventions

Traditional Acupuncture

Treatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner.

Intervention Type: OTHER

Usual Care

Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Chinese aged 18 or above

2. Patient suffering from first ever stroke or recurrent stroke with no urinary symptom in previous episode(s);

3. Patient with classic symptoms, i.e. urgency, urinary frequency or urge incontinence and Overactive Bladder Symptom Score (OABSS) score ≥3 and the urgency item rated as at least 2-point;

4. Not taking any medication for OAB

5. Able to communicate

6. No current acupuncture or transcutaneous electrical nerve stimulation treatment

Exclusion Criteria

1. Urinary retention with post-void urinary volume > 100ml;

2. Current urinary tract infection;

3. Preexisting history of OAB or bladder outlet obstruction or underactive bladder;

4. Significant cognitive impairment with MMSE < or =19;

5. Coexisting Alzheimer's disease, Parkinson's disease, spinal cord disorder or progressive neurological disease such as multiple sclerosis;

6. Active skin lesion or open wound over the needle placement areas;

7. Having valvular heart defects, severe cardiac diseases, or bleeding disorders,

8. Being fitted with any implanted electrical device such as pacemaker, defibrillator, or brain stimulation;

9. Pregnant;

10. Malignancies at the sites of selected acupoints;

11. Receiving acupuncture treatment 1 month before baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Haiyong Chen

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wing Fai Yeung, BCM, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Tung Wah Eastern Hospital

Hong Kong, , Hong Kong

Tung Wah Hospital

Hong Kong, , Hong Kong

Countries

China; Hong Kong

Other Identifiers

AcupPSOAB

Identifier Type: -

Identifier Source: org_study_id