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Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

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

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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Electroacupuncture (EA) group
  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)

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.

Other Name: STN-111, Stratek, Republic of Korea

Sham Comparator: Park sham (PS) group
  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
  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.

Other Name: Park sham device




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819336


Locations
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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
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Principal Investigator: Euiju Lee, Ph.D. Kyunghee University
Publications:

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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    Key Record Dates
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:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders