Overactive Bladder
Conditions
Keywords
Post-stroke
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.
Interventions
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.
OTHERUsual Care
Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Symptom Scale (OABSS) | 1-week posttreatment | four item questionnaire quantifies overactive bladder symptoms in a single score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| AE measured by open-ended questions | first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment | open-ended questions about the experience of adverse events |
Countries
China, Hong Kong
Outcome results
None listed