This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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.
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.
Wonkwang University Gwangju Medical Center
Gwangju, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, South Korea
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.
Time frame: at least 15 days (at most 21 days) (at baseline and the end of the treatment)
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)
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)
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)
Adverse events report
Time frame: intraoperative
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