Electroacupuncture on Post-stroke Urinary Retention

NCT02472288 | Terminated

• 1 other identifier: 2015008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Urinary Retention; Stroke, Complication

Keywords

urinary retention; poststroke; electroacupuncture; randomized controlled trial; effectiveness; safety

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Urinary tract infection (UTI)

  Day 14(endpoint)

• Korean version of Qualiveen Questionnaire (K-QQ)

  Day 0 (baseline), Day 14(endpoint)

• Korean version of International Prostate Symptom Scale (K-IPSS)

  Day 0 (baseline), Day 14(endpoint)

• Blinding Index (BI)

  Day 14(endpoint)

• Frequencies of urination and urinary incontinence

  Day 0 (baseline), Day 14(endpoint)

Other Outcomes (1)

• Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH)

  Day 0 (baseline)

Study Arms (2)

Electroacupuncture (EA) group

EXPERIMENTAL

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

Device: Electroacupuncture (EA)

Sham group

SHAM COMPARATOR

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

Device: Sham electroacupuncture

Interventions

Electroacupuncture (EA) DEVICE

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.

Electroacupuncture (EA) group

Sham electroacupuncture DEVICE

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.

Sham group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead
• Daejeon University: collaborator
• DongGuk University: collaborator

Study Sites (3)

Cheonan Korean Medicine Hospital of the Daejeon University

Cheonan, Chungcheongnam-do, 331-958, South Korea

Location

Dongguk University Ilsan Oriental Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, 156-853, South Korea

Location

Related Publications (20)

• 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.

  PMID: 11083349 BACKGROUND

• 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.

  PMID: 16181941 BACKGROUND

• 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.

  PMID: 20167912 BACKGROUND

• 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.

  PMID: 10753993 BACKGROUND

• 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.

  PMID: 2916918 BACKGROUND

• 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.

  PMID: 20708280 BACKGROUND

• 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.

  PMID: 11291687 BACKGROUND

• 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.

  PMID: 11554277 BACKGROUND

• 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.

  PMID: 23542501 BACKGROUND

• 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.

  PMID: 17970787 BACKGROUND

• 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.

  PMID: 20934242 BACKGROUND

• 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.

  PMID: 21140719 BACKGROUND

• 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.

  PMID: 19678782 BACKGROUND

• 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.

  PMID: 23152677 BACKGROUND

• 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.

  PMID: 4136544 BACKGROUND

• 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.

  PMID: 24484576 BACKGROUND

• 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.

  PMID: 25335150 BACKGROUND

• 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.

  PMID: 15020033 BACKGROUND

• 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.

  PMID: 7512657 BACKGROUND

• 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.

  PMID: 27072880 DERIVED

Related Links

• The Linguistic Validation and Reliability of the Korean Version 'Qualiveen Questionnaire'. Annals of Rehabilitation Medicine. 2010 Oct;34(5):524-43. (in Korean)

MeSH Terms

Conditions

Urinary Retention; Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Euiju Lee, Ph.D.

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

KR (3)