Clinical trial NCT02568774: Acupuncture on Post-Stroke Overactive Bladder
Official title: Acupuncture on Post-Stroke Overactive Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Post-stroke
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overactive Bladder Symptom Scale (OABSS)
timeFrame: 1-week posttreatment
Secondary outcomes:
measure: Number of incontinent episodes measured by bladder diary
timeFrame: 1-week posttreatment, 4-week posttreatment
measure: Stroke Specific Quality of Life Scale (SS-QoLS)
timeFrame: 1-week posttreatment, 4-week posttreatment
measure: Medication measured by bladder diary
timeFrame: 1-week posttreatment, 4-week posttreatment
Other outcomes:
measure: AE measured by open-ended questions
timeFrame: first week of treatment, second week of treatment, third week of treatment, 1-week posttreatment, 4-week posttreatment
Locations:
city: Shanghai
country: China
facility: Shanghai TCM-INTEGRATED Hospital, Shanghai University of Traditional Chinese Medicine
city: Hong Kong
country: Hong Kong
facility: Tung Wah Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wing Fai Yeung, BCM, PhD
role: PRINCIPAL_INVESTIGATOR
References: