Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

NCT02819336 | Completed

• 2 other identifiers: 2016006KOMCIRB-160215-HR-006
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Urinary Incontinence; Stroke, Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

• 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)

• The Lower urinary track system Outcome Score (LOS)

  at least 15 days (at most 21 days) (at baseline and the end of the treatment)

• Adverse events report

  intraoperative

Other Outcomes (1)

• Blinding Index (BI)

  21 days

Study Arms (2)

Electroacupuncture (EA) group

EXPERIMENTAL

1. Electroacupuncture therapy (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with middle frequency (30 Hz) of electrical stimulation 4. 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)

Park sham (PS) group

SHAM COMPARATOR

1. Non-penetrating Park sham electroacupuncture treatment (10 sessions within 21 days) 2. CV2, CV3, CV4, CV6, and bilateral points of SP11, SP6 (8 acupoints in total) 3. 20 minutes duration with undelivered electrostimulation of middle frequency (30 Hz) 4. 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

Interventions

Electroacupuncture (EA) DEVICE

The EA group will receive the verum therapies using the following procedures. 1. Let the patient lie down on lateral decubitus. 2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6. 3. 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) 4. 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) 5. The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.

Also known as: STN-111, Stratek, Republic of Korea

Electroacupuncture (EA) group

Sham electroacupuncture DEVICE

1. Let the patient lie down on lateral decubitus. 2. The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally \& SP11 and SP6 bilaterally. 3. The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube. 4. 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. 5. The practitioner should have at least 1-year clinical experiences. The procedure will be repeated 10 times (once a session) within 21 days.

Also known as: Park sham device

Park sham (PS) 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 years old
• Patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years
• Twice or more of urination with 3 to 4 points of PPIUS\* at baseline OR 13 points or more of K-IPSS\*
• Any volunteers who signed the informed consent forms

You may not qualify if:

• Once or more of post-voiding residual \> 200 ml per day
• Clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision
• Recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year
• Cognitive impairment with less than 23 points of MMSE-K\* examination
• Acute or chronic lower urinary tract infection examined by urine culture
• Urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history
• Any severe diseases in lower urinary tract based on medical history and screening examination
• Coagulation disorders based on medical history
• Peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history
• Psychiatric diseases based on medical history
• Fear of acupuncture based on questionnaire test
• Pregnancy based on urine test
• 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

Sponsors & Collaborators

• Kyunghee University: lead
• Wonkwang University Gwangju Medical Center: collaborator

Study Sites (2)

Wonkwang University Gwangju Medical Center

Gwangju, 61729, South Korea

Location

Kyung Hee University Korean Medicine Hospital

Seoul, 156-853, South Korea

Location

Related Publications (17)

• Currie CT. Urinary incontinence after stroke. Br Med J (Clin Res Ed). 1986 Nov 22;293(6558):1322-3. doi: 10.1136/bmj.293.6558.1322-a. No abstract available.

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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. doi: 10.1161/01.str.24.3.378.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 23932438 BACKGROUND

• 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.

  PMID: 24712917 BACKGROUND

• 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. doi: 10.1016/S0022-5347(05)00348-4.

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• 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.

  PMID: 23235974 BACKGROUND

• 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.

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MeSH Terms

Conditions

Urinary Incontinence; Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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 28, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)