Urinary Retention, Stroke, Complication
Conditions
Keywords
urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety
Brief summary
This study aimed to evaluate the effectiveness of adjuvant electroacupuncture therapy for the post-stroke patients with urinary retention under conventional treatments, compared with sham electroacupuncture.
Interventions
DEVICEElectroacupuncture (EA)
The EA group receives 10 sessions of EA therapy (5 per a week, 2 weeks). After inserting needles by 5-10 mm (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Korea) using the Park sham guide tube on the 8 points (BL31, BL32, BL33, and BL34, bilateral sides), de qi response is elicited. The electrical stimulation is then presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea). Conventional treatments (western/traditional herbal medications, rehabilitation, or acupuncture without electro-stimulation for stroke, and western/traditional herbal medications or acupuncture without electro-stimulation for urinary retention) are allowed during the intervention period. The practitioner should have over 1-year clinical experiences.
DEVICESham electroacupuncture
The patients in sham group receive totally 10 sessions of the sham EA (5 sessions per a week, for 2 weeks). Non-penetrating needles of Park sham device are implemented on the bilateral points of BL31, BL32, BL33, and BL34 (total 8 acupoints). Then, the electro-stimulation is presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea), even though the electrical stimulation is not delivered through the skin. Conventional treatments for stroke and urinary retention along with EAT are not eliminated. It is also necessary for the practitioner with more than 1-year experiences on the clinical field.
Sponsors
Daejeon University
DongGuk University
Kyunghee University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female aged over 19 * Patients diagnosed with stroke (cerebral hemorrhage or infarction) based on the CT or MRI examination * Those whose onset is within 2 years * Those who have urinary retention after stroke onset (every PVR result is equal or more than 100ml on the 2 consecutive tests) * Those who signed on the informed consent form
Exclusion criteria
* Patients who have any bleeding disorders based on medical history hearing * Patients who have ever had any medical procedures or surgeries for peripheral vascular diseases based on medical history hearing * Patients who have any psychiatry disorders based on medical history hearing * Patients who have any severe diseases in lower urinary tract symptom based on medical history hearing * Patients who have any acute or chronic infectious diseases in lower urinary tract symptom based on medical history hearing * Acute stage stroke patients (onset within 1 week) whose Glasgow Coma Scale ≤ 8 * Patients who have fear about acupuncture * Patients who have changed medications for urinary retention or relevant symptoms, such as urinary incontinence drugs or diuretics, within 3 days * Female who diagnosed with pregnancy by urinalysis * Those who primary or sub investigators judge not to be suitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint | Day 0 (baseline), Day 14(endpoint) | * daily PVR ratio = daily PVR urine volume / (daily PVR urine volume + self voiding volume) * Baseline measurement: daily PVR ratio for 24 hours on the day before the first intervention day Endpoint measurement: daily PVR ratio for 24 hours within 3 days after the last intervention day * If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then the urine volume is measured on the next day of the last intervention. * If more than 7 sessions of EA or sham EA are completed and urinary tract is infected at the end, then the urine volume is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary tract infection (UTI) | Day 14(endpoint) | After 7-10 sessions of the EA or sham EA, patients get urinalysis to figure out whether UTI exists. If a patient has UTI, he/she gets antibiotics for 48 hours. When no UTI is found with reexamination of urinalysis, then daily PVR is going to be assessed and included in the final ITT (Intention To Treat) analysis. Otherwise, the data from the patients will be included only in the PP (Per Protocol) analysis. |
| Korean version of Qualiveen Questionnaire (K-QQ) | Day 0 (baseline), Day 14(endpoint) | * The disease-specific QoL (quality of life) assessment scale for neurogenic bladder * Consisting of 30 items and each item is scored by 0 to 4. (The higher score in K-QQ is, the lower QoL of the patients is.) * The reliability and validity of K-QQ has been acquired in the previous studies. * If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then K-QQ is measured on the next day of the last intervention. * If more than 7 sessions of EA or sham EA are completed and urinary tract is infected at the end, then K-QQ is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours. |
| Korean version of International Prostate Symptom Scale (K-IPSS) | Day 0 (baseline), Day 14(endpoint) | * Assessment tool for symptoms in lower urinary tract * Consisting of 7 items (0 to 5 scores) * If more than 7 sessions of EA or sham EA are completed and urinary tract is not infected at the end, then K-IPSS is measured on the next day of the last intervention. * If more than 7 sessions of EA or sham EA treatment are completed and urinary tract is infected at the end, then K-IPSS is measured on the 3rd day of the last intervention after anti-infection treatment is carried out for 48 hours. |
| Frequencies of urination and urinary incontinence | Day 0 (baseline), Day 14(endpoint) | * Record of the frequencies of urination and urinary incontinence by urinary diary * 1 day before the first intervention and another day after the last intervention * Mean change between post- and pre-treatments in EA group comparing with the sham group |
| Adverse events | Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14) | * Ask any adverse events after EA or sham interventions and record them in case report forms * Evaluate the severity, seriousness, and relevance to the study |
| Blinding Index (BI) | Day 14(endpoint) | * Assessment of patients' blinding * Patients are asked which group you think you belong to during the study, and they selects one of the options, EA group, sham group, or Not knowing. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) | Day 0 (baseline) | Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history. |
Countries
South Korea
Outcome results
None listed