Acupuncture on Post-Stroke Overactive Bladder

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Other: Usual Care; Other: Traditional Acupuncture

• Registration Number: NCT02568774
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2015-06-13
• Study Start: 2015-08
• Study First Submitted QC: 2015-10-04
• Study First Posted: 2015-10-06
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
Traditional Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Overactive Bladder Symptom Scale (OABSS)	1-week posttreatment	four item questionnaire quantifies overactive bladder symptoms in a single score

Secondary Outcome Measures

Name	Time	Method
Stroke Specific Quality of Life Scale (SS-QoLS)	1-week posttreatment, 4-week posttreatment	12 items questionnaire consists of physical and psychosocial subscales: amount of help required completing a task, trouble experienced performing a task and functioning.
Medication measured by bladder diary	1-week posttreatment, 4-week posttreatment	number of patients requested medication for OAB from bladder diary.
Number of incontinent episodes measured by bladder diary	1-week posttreatment, 4-week posttreatment	Record the frequency of day and night time voiding and incontinence episodes over 3 day periods

Trial Locations

Locations (3)

Tung Wah Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong

Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China

Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong