Electroacupuncture on Post-stroke Urinary Retention

Urinary Retention Clinical Trial

Official title:

Multicenter, Randomised Controlled Trial of Electroacupuncture Versus Sham Electroacupuncture for Urinary Retention of Poststroke Patients: a Study Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02472288
• Other study ID #: 2015008
• Status: Terminated
• Phase: N/A
• First received: June 9, 2015
• Last updated: August 29, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Kyunghee University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke, Complication
• Urinary Retention

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Cheonan Korean Medicine Hospital of the Daejeon University	Cheonan	Chungcheongnam-do
Korea, Republic of	Dongguk University Ilsan Oriental Hospital	Goyang	Gyeonggi-do
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Kyunghee University	Daejeon University, DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (19)

Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. — View Citation

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. — View Citation

Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. Review. — View Citation

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. Epub 2007 Oct 26. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kong KH, Young S. Incidence and outcome of poststroke urinary retention: a prospective study. Arch Phys Med Rehabil. 2000 Nov;81(11):1464-7. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes mellitus (DM) and benign prostatic hyperplasia (BPH)	Check of diabetes mellitus (DM) and benign prostatic hyperplasia (BPH) in medical history.	Day 0 (baseline)	No
Primary	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)	No
Secondary	Urinary tract infection (UTI)	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.	Day 14(endpoint)	No
Secondary	Korean version of Qualiveen Questionnaire (K-QQ)	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.	Day 0 (baseline), Day 14(endpoint)	No
Secondary	Korean version of International Prostate Symptom Scale (K-IPSS)	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.	Day 0 (baseline), Day 14(endpoint)	No
Secondary	Blinding Index (BI)	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.	Day 14(endpoint)	No
Secondary	Frequencies of urination and urinary incontinence	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	Day 0 (baseline), Day 14(endpoint)	No
Secondary	Adverse events	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	Every treatment visit (5 times during Day 1~Day 7 & 5 times during Day 8~Day 14)	Yes