Clinical trial NCT02472288: Electroacupuncture on Post-stroke Urinary Retention
Official title: Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Stroke, Complication
Keywords: urinary retention
poststroke
electroacupuncture
randomized controlled trial
effectiveness
safety
Lead sponsor: Kyunghee University
Sponsor class: OTHER
Collaborators: name: Daejeon University
name: DongGuk University
First posted: 2015-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint
timeFrame: Day 0 (baseline), Day 14(endpoint)
Secondary outcomes:
measure: Urinary tract infection (UTI)
timeFrame: Day 14(endpoint)
measure: Korean version of Qualiveen Questionnaire (K-QQ)
timeFrame: Day 0 (baseline), Day 14(endpoint)
measure: Korean version of International Prostate Symptom Scale (K-IPSS)
timeFrame: Day 0 (baseline), Day 14(endpoint)
measure: Blinding Index (BI)
timeFrame: Day 14(endpoint)
measure: Frequencies of urination and urinary incontinence
timeFrame: Day 0 (baseline), Day 14(endpoint)
measure: Adverse events
timeFrame: Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
Other outcomes:
measure: Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH)
timeFrame: Day 0 (baseline)
Locations:
city: Cheonan
country: Korea, Republic of
facility: Cheonan Korean Medicine Hospital of the Daejeon University
state: Chungcheongnam-do
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Oriental Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Korean Medicine Hospital
Study officials:
affiliation: Kyunghee University
name: Euiju Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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