Electroacupuncture on Post-stroke Urinary Retention

Not Applicable

Terminated

• Conditions: Urinary Retention; Stroke, Complication
• Interventions: Device: Electroacupuncture (EA); Device: Sham electroacupuncture

• Registration Number: NCT02472288
• Lead Sponsor: Kyunghee University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture (EA) group	Electroacupuncture (EA)	1. Electroacupuncture therapy (10 sessions in total, 5 per a week, 2 weeks) 2. BL31, BL32, BL33, and BL34 (total 8 acupoints, bilateral) 3. 20 minutes duration, middle frequency (30 Hz) of electrical stimulation 4. conventional treatments permitted
Sham group	Sham electroacupuncture	1. Non-penetrating Park sham electroacupuncture treatment (10 sessions in total, 5 per a week, 2 weeks) 2. BL31, BL32, BL33, and BL34 (total 8 acupoints on the right and left sides) 3. 20 minutes duration, undelivered electrostimulation of middle frequency (30 Hz) 4. conventional treatments permitted

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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

Trial Locations

Locations (3)

Cheonan Korean Medicine Hospital of the Daejeon University; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of

Kyung Hee University Korean Medicine Hospital; 🇰🇷 Seoul, Korea, Republic of

Dongguk University Ilsan Oriental Hospital; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of