Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

June 25, 2017 updated by: Lee Eui-ju, Kyunghee University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61729
        • Wonkwang University Gwangju Medical Center
      • Seoul, Korea, Republic of, 156-853
        • Kyung Hee University Korean Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Park sham device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at least 15 days (at most 21 days) (at baseline and the end of the treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
Time Frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
at least 15 days (at most 21 days) (at baseline and the end of the treatment)
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)
at least 15 days (at most 21 days) (at baseline and the end of the treatment)
Adverse events report
Time Frame: intraoperative
intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University

Collaborators

Wonkwang University Gwangju Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 25, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016006
  • KOMCIRB-160215-HR-006 (OTHER: IRB of Kyung Hee University Korean Medicine Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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