Urinary Retention Clinical Trial
Official title:
Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
Verified date | August 2016 |
Source | Kyunghee University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry of Food and Drug Safety |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Cheonan Korean Medicine Hospital of the Daejeon University | Cheonan | Chungcheongnam-do |
Korea, Republic of | Dongguk University Ilsan Oriental Hospital | Goyang | Gyeonggi-do |
Korea, Republic of | Kyung Hee University Korean Medicine Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University | Daejeon University, DongGuk University |
Korea, Republic of,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) | Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history. | Day 0 (baseline) | No |
Primary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | Yes |
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