Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819336
• Other study ID #: 2016006
• Secondary ID: KOMCIRB-160215-H
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: June 25, 2017
• Start date: June 2016
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: Kyunghee University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 1, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Male or female aged over 19 years old

2. Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years

3. Twice or more of urination with 3 to 4 points of PPIUS* at baseline OR 13 points or more of K-IPSS*

4. Any volunteers who signed the informed consent forms

Exclusion Criteria: We will exclude any patients with

1. Once or more of post-voiding residual > 200 ml per day

2. Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision

3. Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year

4. Cognitive impairment with less than 23 points of MMSE-K* examination

5. Acute or chronic lower urinary tract infection examined by urine culture

6. Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history

7. Any severe diseases in lower urinary tract based on medical history and screening examination

8. Coagulation disorders based on medical history

9. Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history

10. Psychiatric diseases based on medical history

11. Fear of acupuncture based on questionnaire test

12. Pregnancy based on urine test

13. Any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial

• Abbreviations PPIUS; Patient Perception of Intensity of Urgency Scale K-IPSS; The Korean version of International Prostate Symptom Scale MMSE-K; The Korean version of Mini-Mental State Examination

Related Conditions & MeSH terms

• Enuresis
• Stroke, Complication
• Urinary Incontinence

Intervention

Device:
• Electroacupuncture (EA)
The EA group will receive the verum therapies using the following procedures. Let the patient lie down on lateral decubitus. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6. The verum acupunctures are inserted on each acupoint inside the installed guide-tube. (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Republic of Korea) After de qi response is elicited, the electrical stimulation is presented for 20 minutes by middle frequency (30 Hz). (STN-111, Stratek, Republic of Korea) The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.
• Sham electroacupuncture
Let the patient lie down on lateral decubitus. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally & SP11 and SP6 bilaterally. The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube. The electrical stimulation is presented for 20 minutes by middle frequency (30 Hz), (STN-111, Stratek, Republic of Korea) even though the electrical stimulation is not delivered through the skin because the needles are not penetrated through the skin. The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.

Locations

Country	Name	City	State
Korea, Republic of	Wonkwang University Gwangju Medical Center	Gwangju
Korea, Republic of	Kyung Hee University Korean Medicine Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University	Wonkwang University Gwangju Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (17)

Abrams P, Avery K, Gardener N, Donovan J; ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006 Mar;175(3 Pt 1):1063-6; discussion 1066. — View Citation

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

Chapple CR, Drake MJ, Van Kerrebroeck P, Cardozo L, Drogendijk T, Klaver M, Van Charldorp K, Hakimi Z, Compion G. Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms. BJU Int. 2014 May;113(5):696-703. doi: 10.1111/bju.12555. Epub 2014 Feb 20. Review. — View Citation

Currie CT. Urinary incontinence after stroke. Br Med J (Clin Res Ed). 1986 Nov 22;293(6558):1322-3. Erratum in: Br Med J (Clin Res Ed) 1986 Dec 13;293(6561)1524. — 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

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

Gelber DA, Good DC, Laven LJ, Verhulst SJ. Causes of urinary incontinence after acute hemispheric stroke. Stroke. 1993 Mar;24(3):378-82. — View Citation

Hajebrahimi S, Nourizadeh D, Hamedani R, Pezeshki MZ. Validity and reliability of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and its correlation with urodynamic findings. Urol J. 2012 Fall;9(4):685-90. — 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

Kang SG, Park CH, Kim DK, Park JK, Hong SJ, Chung BH, Kim CS, Lee KS, Kim JC, Lee JG. Long-term outcome of tamsulosin for patients with lower urinary tract symptoms according to the treatment response defined by lower urinary tract symptom outcomes score. Int J Clin Pract. 2011 Jun;65(6):691-7. doi: 10.1111/j.1742-1241.2011.02667.x. — View Citation

Mehdi Z, Birns J, Bhalla A. Post-stroke urinary incontinence. Int J Clin Pract. 2013 Nov;67(11):1128-37. doi: 10.1111/ijcp.12183. Epub 2013 Jul 8. Review. — 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

Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. Erratum in: Neurourol Urodyn. 2008;27(1):100. — 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

van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blinding Index (BI)	Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not.	21 days
Primary	Total Urgency and Frequency Score (TUFS)	The patients will be asked to fill the scale about their perception of urgency intensity (24 hours before the 1st session and after the last session, respectively) by themselves. They have to record every time of urination and select one of the 5 levels in perception of urgency intensity (0=No urgency, 1=Mild urgency, 2=Moderate urgency, 3=Severe urgency, 4= urgency incontinence) for 24 hours at baseline and the end of the treatment, respectively.	at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Secondary	International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)		at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Secondary	The Korean version of International Prostate Symptom Scale (K-IPSS)		at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Secondary	The Lower urinary track system Outcome Score (LOS)		at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Secondary	Adverse events report		intraoperative