Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2015-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture (EA) group
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
Electroacupuncture (EA)
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.
Sham group
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
Sham electroacupuncture
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.
Interventions
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Electroacupuncture (EA)
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.
Sham electroacupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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Daejeon University
OTHER
DongGuk University
OTHER
Kyunghee University
OTHER
Responsible Party
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Lee Eui-ju
Professor
Principal Investigators
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Euiju Lee, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University
Locations
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Cheonan Korean Medicine Hospital of the Daejeon University
Cheonan, Chungcheongnam-do, South Korea
Dongguk University Ilsan Oriental Hospital
Goyang-si, Gyeonggi-do, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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The Linguistic Validation and Reliability of the Korean Version 'Qualiveen Questionnaire'. Annals of Rehabilitation Medicine. 2010 Oct;34(5):524-43. (in Korean)
Other Identifiers
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2015008
Identifier Type: -
Identifier Source: org_study_id
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