- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472288
Electroacupuncture on Post-stroke Urinary Retention
August 29, 2016 updated by: Lee Eui-ju, Kyunghee University
Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 156-853
- Kyung Hee University Korean Medicine Hospital
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Chungcheongnam-do
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Cheonan, Chungcheongnam-do, Korea, Republic of, 331-958
- Cheonan Korean Medicine Hospital of the Daejeon University
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Gyeonggi-do
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Goyang, Gyeonggi-do, Korea, Republic of, 410-773
- Dongguk University Ilsan Oriental Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electroacupuncture (EA) group
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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.
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Sham Comparator: Sham group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of daily PVR (Postvoid Residual) urine ratios between the baseline and the endpoint
Time Frame: Day 0 (baseline), Day 14(endpoint)
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Day 0 (baseline), Day 14(endpoint)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary tract infection (UTI)
Time Frame: Day 14(endpoint)
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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.
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Day 14(endpoint)
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Korean version of Qualiveen Questionnaire (K-QQ)
Time Frame: Day 0 (baseline), Day 14(endpoint)
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Day 0 (baseline), Day 14(endpoint)
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Korean version of International Prostate Symptom Scale (K-IPSS)
Time Frame: Day 0 (baseline), Day 14(endpoint)
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Day 0 (baseline), Day 14(endpoint)
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Blinding Index (BI)
Time Frame: Day 14(endpoint)
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Day 14(endpoint)
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Frequencies of urination and urinary incontinence
Time Frame: Day 0 (baseline), Day 14(endpoint)
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Day 0 (baseline), Day 14(endpoint)
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Adverse events
Time Frame: Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
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Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH)
Time Frame: Day 0 (baseline)
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Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history.
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Day 0 (baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
- Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
- Kong KH, Young S. Incidence and outcome of poststroke urinary retention: a prospective study. Arch Phys Med Rehabil. 2000 Nov;81(11):1464-7. doi: 10.1053/apmr.2000.9630.
- Wu J, Baguley IJ. Urinary retention in a general rehabilitation unit: prevalence, clinical outcome, and the role of screening. Arch Phys Med Rehabil. 2005 Sep;86(9):1772-7. doi: 10.1016/j.apmr.2005.01.012.
- Wu P, Mills E, Moher D, Seely D. Acupuncture in poststroke rehabilitation: a systematic review and meta-analysis of randomized trials. Stroke. 2010 Apr;41(4):e171-9. doi: 10.1161/STROKEAHA.109.573576. Epub 2010 Feb 18.
- Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886.
- Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3.
- Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12.
- Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804.
- Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4.
- Smith MD, Seth JH, Fowler CJ, Miller RF, Panicker JN. Urinary retention for the neurologist. Pract Neurol. 2013 Oct;13(5):288-91. doi: 10.1136/practneurol-2012-000478. Epub 2013 Mar 29.
- Datta SN, Chaliha C, Singh A, Gonzales G, Mishra VC, Kavia RB, Kitchen N, Fowler CJ, Elneil S. Sacral neurostimulation for urinary retention: 10-year experience from one UK centre. BJU Int. 2008 Jan;101(2):192-6. doi: 10.1111/j.1464-410X.2007.07282.x. Epub 2007 Oct 26.
- Kessler TM, La Framboise D, Trelle S, Fowler CJ, Kiss G, Pannek J, Schurch B, Sievert KD, Engeler DS. Sacral neuromodulation for neurogenic lower urinary tract dysfunction: systematic review and meta-analysis. Eur Urol. 2010 Dec;58(6):865-74. doi: 10.1016/j.eururo.2010.09.024. Epub 2010 Oct 1.
- Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x.
- Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009 Aug;15(8):905-9. doi: 10.1089/acm.2009.0062.
- Yu KW, Lin CL, Hung CC, Chou EC, Hsieh YL, Li TM, Chou LW. Effects of electroacupuncture on recent stroke inpatients with incomplete bladder emptying: a preliminary study. Clin Interv Aging. 2012;7:469-74. doi: 10.2147/CIA.S37531. Epub 2012 Nov 8.
- Rowe TA, Juthani-Mehta M. Diagnosis and management of urinary tract infection in older adults. Infect Dis Clin North Am. 2014 Mar;28(1):75-89. doi: 10.1016/j.idc.2013.10.004. Epub 2013 Dec 8.
- Grigoryan L, Trautner BW, Gupta K. Diagnosis and management of urinary tract infections in the outpatient setting: a review. JAMA. 2014 Oct 22-29;312(16):1677-84. doi: 10.1001/jama.2014.12842.
- Sagnier PP, MacFarlane G, Richard F, Botto H, Teillac P, Boyle P. Results of an epidemiological survey using a modified American Urological Association symptom index for benign prostatic hyperplasia in France. J Urol. 1994 May;151(5):1266-70. doi: 10.1016/s0022-5347(17)35229-1.
- Shin S, Lee J, Yoo J, Lim SM, Lee E. Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial. Trials. 2016 Apr 12;17:197. doi: 10.1186/s13063-016-1315-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
June 9, 2015
First Submitted That Met QC Criteria
June 10, 2015
First Posted (Estimate)
June 15, 2015
Study Record Updates
Last Update Posted (Estimate)
August 31, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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