Electroacupuncture on Post-stroke Urinary Retention

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol

Conditions
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Urinary Retention, Stroke, Complication

Intervention / Treatment
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* Device: Electroacupuncture (EA)
* Device: Sham electroacupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture (EA) group<br>Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral) 20 minutes duration, middle frequency (30 Hz) of electrical stimulation conventional treatments permitted | Device: Electroacupuncture (EA)<br>* 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.<br>|
| Sham Comparator: Sham group<br>Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks) BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides) 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz) conventional treatments permitted | Device: Sham electroacupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the 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. | Day 0 (baseline), Day 14(endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection (UTI) | 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. | Day 14(endpoint) | 
| Korean version of Qualiveen Questionnaire (K-QQ) | 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. | Day 0 (baseline), Day 14(endpoint) | 
| Korean version of International Prostate Symptom Scale (K-IPSS) | 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. | Day 0 (baseline), Day 14(endpoint) | 
| Blinding Index (BI) | 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. | Day 14(endpoint) | 
| Frequencies of urination and urinary incontinence | 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 | Day 0 (baseline), Day 14(endpoint) | 
| Adverse events | 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 | Every treatment visit (5 times during Day 1 Day 7 & 5 times during Day 8 Day 14) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary retention, poststroke, electroacupuncture, randomized controlled trial, effectiveness, safety