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Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

Primary Purpose

Urinary Incontinence, Stroke, Complication

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Electroacupuncture (EA)

Sham electroacupuncture

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, electroacupuncture, stroke, complications, randomized controlled trial, pilot projects

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria: We will exclude any patients with

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

Sites / Locations

Wonkwang University Gwangju Medical Center
Kyung Hee University Korean Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture (EA) group

Park sham (PS) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form (ICIQ-UI-SF)

The Korean version of International Prostate Symptom Scale (K-IPSS)

The Lower urinary track system Outcome Score (LOS)

Adverse events report

Full Information

NCT ID

NCT02819336

First Posted

June 28, 2016

Last Updated

June 25, 2017

Sponsor

Kyunghee University

Collaborators

Wonkwang University Gwangju Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02819336

Brief Title

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyunghee University

Collaborators

Wonkwang University Gwangju Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Stroke, Complication

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture (EA) group

Arm Type

Experimental

Arm Description

Arm Title

Park sham (PS) group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Electroacupuncture (EA)

Other Intervention Name(s)

STN-111, Stratek, Republic of Korea

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham electroacupuncture

Other Intervention Name(s)

Park sham device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total Urgency and Frequency Score (TUFS)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Title

Adverse events report

Time Frame

intraoperative

Other Pre-specified Outcome Measures:

Title

Blinding Index (BI)

Description

Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not.

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: We will exclude any patients with 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Euiju Lee, Ph.D.

Organizational Affiliation

Kyunghee University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wonkwang University Gwangju Medical Center

City

Gwangju

ZIP/Postal Code

61729

Country

Korea, Republic of

Facility Name

Kyung Hee University Korean Medicine Hospital

City

Seoul

ZIP/Postal Code

156-853

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

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