Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial

Authors: Seungwon Shin, Jiwon Lee, Junghee Yoo, Sung Min Lim, Euiju Lee

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control.

Methods/design

A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups.
They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA.
Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles.

Discussion

The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors.

Trial Registration

This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.
Literature
1.
Kong KH, Young S. Incidence and outcome of poststroke urinary retention: a prospective study. Arch Phys Med Rehabil. 2000;81:1464–7.CrossRefPubMed
2.
Yu KW, Lin CL, Hung CC, Chou EC, Hsieh YL, Li TM, et al. Effects of electroacupuncture on recent stroke inpatients with incomplete bladder emptying: a preliminary study. Clin Interv Aging. 2012;7:469–74.PubMedPubMedCentral
3.
Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989;70:41–3.PubMed
4.
Anderson CS, Jamrozik KD, Broadhurst RJ, Stewart-Wynne EG. Predicting survival for 1 year among different subtypes of stroke. Results from the Perth Community Stroke Study. Stroke. 1994;25:1935–44.CrossRefPubMed
5.
Taub NA, Wolfe CD, Richardson E, Burney PG. Predicting the disability of first-time stroke sufferers at 1 year. 12-month follow-up of a population-based cohort in southeast England. Stroke. 1994;25:352–7.CrossRefPubMed
6.
Patel M, Coshall C, Rudd AG, Wolfe CD. Natural history and effects on 2-year outcomes of urinary incontinence after stroke. Stroke. 2001;32:122–7.CrossRefPubMed
7.
Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001;35:44–8.PubMed
8.
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;53:e125–8.CrossRefPubMed
9.
Datta SN, Chaliha C, Singh A, Gonzales G, Mishra VC, Kavia RB, et al. Sacral neurostimulation for urinary retention: 10-year experience from one UK centre. BJU Int. 2008;101:192–6.PubMed
10.
Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009;15:905–9.CrossRefPubMed
11.
Liu Y, Liu L, Wang X. Electroacupuncture at points Baliao and Huiyang (BL35) for post-stroke detrusor overactivity. Neural Regen Res. 2013;8:1663–72.PubMedPubMedCentral
12.
Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18.CrossRefPubMedPubMedCentral
13.
MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7:e1000261.CrossRefPubMedPubMedCentral
14.
Korean Acupuncture & Moxibustion Society. Acupunture & Moxibustion. Seoul: Jipmudang; 2008.
15.
WHO Regional Office for the Western Pacific. WHO standard acupuncture point locations in the Western Pacific Region. Manila: World Health Organization; 2008.
16.
Xie H, Li X, Lai J, Zhou Y, Wang C, Liang J. Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial. Trials. 2014;15:397.CrossRefPubMedPubMedCentral
17.
Clinical Research Center for Stroke. Clinical practice guidelines for stroke (revision 2015.03.). Seoul: Clinical Research Center for Stroke; 2015.
18.
Stern JA, Hsieh YC, Schaeffer AJ. Residual urine in an elderly female population: novel implications for oral estrogen replacement and impact on recurrent urinary tract infection. J Urol. 2004;171:768–70.CrossRefPubMed
19.
Truzzi JC, Almeida FM, Nunes EC, Sadi MV. Residual urinary volume and urinary tract infection—when are they linked? J Urol. 2008;180:182–5.CrossRefPubMed
20.
Rowe TA, Juthani-Mehta M. Diagnosis and management of urinary tract infection in older adults. Infect Clin North Am. 2014;28:75–89.CrossRef
21.
Bonniaud V, Bryant D, Parratte B, Gallien P, Guyatt G. Qualiveen: a urinary disorder-specific instrument for use in clinical trials in multiple sclerosis. Arch Phys Med Rehabil. 2006;87:1661–3.CrossRefPubMed
22.
Bonniaud V, Parratte B, Amarenco G, Jackowski D, Didier JP, Guyatt G. Measuring quality of life in multiple sclerosis patients with urinary disorders using the Qualiveen questionnaire. Arch Phys Med Rehabil. 2004;85:1317–23.CrossRefPubMed
23.
Costa P, Perrouin-Verbe B, Colvez A, Didier J, Marquis P, Marrel A, et al. Quality of life in spinal cord injury patients with urinary difficulties. Development and validation of Qualiveen. Eur Urol. 2001;39:107–13.CrossRefPubMed
24.
Lee YS, Kim ES, Oh SJ, Lee BS, Kim DA. The linguistic validation and reliability of the Korean version “Qualiveen questionnaire”. J Korean Acad Rehabil Med. 2010;34:524–43.
25.
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;151:1266–70.PubMed
26.
Choi HR, Chung WS, Shim BS, Kwon SW, Hong SJ, Chung BH, et al. Translation validity and reliability of I-PSS Korean version. Korean J Urol. 1996;37:659–65.
27.
Bang HJ, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25:143–56.CrossRefPubMed
28.
Fleiss JL, Levin B, Paik MC. Statistical methods for rates and proportions. 3rd ed. Hoboken: John Wiley & Sons; 2013.
29.
Park JB, White A, Lee HJ, Ernst E. Development of a new sham needle. Acupunct Med. 1999;17:110–2.CrossRef
30.
Park JB, White A, Stevinson C, Ernst E, James M. Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med. 2002;20:168–74.CrossRefPubMed
Metadata
Title
Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial
Authors
Seungwon Shin
Jiwon Lee
Junghee Yoo
Sung Min Lim
Euiju Lee
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1315-3

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

Design and rationale of the ATHENA study – A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial

Study protocol

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial

Study protocol

The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial

Commentary

Trialling of an optimal health programme (OHP) across chronic disease

Study protocol

Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial

Research

Assessment of clinical trial participant patient satisfaction: a call to action