Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

• ClinicalTrials.gov Identifier: NCT02819336
• Recruitment Status: Completed
• First Posted: June 30, 2016
• Last Update Posted: June 27, 2017
• Sponsor: Kyunghee University
• Collaborator: Wonkwang University Gwangju Medical Center
• Information provided by (Responsible Party): Lee Eui-ju, Kyunghee University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence; Stroke, Complication	Device: Electroacupuncture (EA); Device: Sham electroacupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: April 2017
• Actual Study Completion Date: June 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Electroacupuncture (EA) group; Electroacupuncture therapy (10 sessions within 21 days); CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total); 20 minutes duration with middle frequency (30 Hz) of electrical stimulation; Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.	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.; Other Name: STN-111, Stratek, Republic of Korea
Sham Comparator: Park sham (PS) group; Non-penetrating Park sham electroacupuncture treatment (10 sessions within 21 days); CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total); 20 minutes duration with undelivered electrostimulation of middle frequency (30 Hz); Conventional treatments (drugs, traditional herbal medications, rehabilitation therapies, or acupuncture therapies without electrostimulation for stroke and urinary incontinence / electroacupuncture therapies other than the acupoints (CV2, CV3, CV4, CV6, SP1 and SP6) for stroke and urinary incontinence) are permitted.	Device: 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.; Other Name: Park sham device

Outcome Measures

Primary Outcome Measures :

1. Total Urgency and Frequency Score (TUFS) [ Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment) ]
   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.

Secondary Outcome Measures :

1. International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF) [ Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment) ]
2. The Korean version of International Prostate Symptom Scale (K-IPSS) [ Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment) ]
3. The Lower urinary track system Outcome Score (LOS) [ Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment) ]
4. Adverse events report [ Time Frame: intraoperative ]

Other Outcome Measures:

1. Blinding Index (BI) [ Time Frame: 21 days ]
   Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Wonkwang University Gwangju Medical Center

Gwangju, Korea, Republic of, 61729

Kyung Hee University Korean Medicine Hospital

Seoul, Korea, Republic of, 156-853

Sponsors and Collaborators

Kyunghee University

Wonkwang University Gwangju Medical Center

Investigators

• Principal Investigator: Euiju Lee, Ph.D.; Kyunghee University

More Information

Publications:

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

• Responsible Party: Lee Eui-ju, Professor, Kyunghee University
• ClinicalTrials.gov Identifier: NCT02819336
• Other Study ID Numbers: 2016006; KOMCIRB-160215-HR-006 ( Other Identifier: IRB of Kyung Hee University Korean Medicine Hospital )
• First Posted: June 30, 2016
• Last Update Posted: June 27, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Lee Eui-ju, Kyunghee University:

urinary incontinence; electroacupuncture; stroke; complications; randomized controlled trial; pilot projects

Additional relevant MeSH terms:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders