Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence

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

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

Conditions
-----------------
Urinary Incontinence, Stroke, Complication

Intervention / Treatment
-----------------
* Device: Electroacupuncture (EA)
* Device: Sham electroacupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture (EA) group<br>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)<br>* 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.<br>* Other names: STN-111, Stratek, Republic of Korea;|
| Sham Comparator: Park sham (PS) group<br>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<br>* 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.<br>* 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) | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence, electroacupuncture, stroke, complications, randomized controlled trial, pilot projects