Urinary Incontinence, Stroke, Complication
Conditions
Keywords
urinary incontinence, electroacupuncture, stroke, complications, randomized controlled trial, pilot projects
Brief summary
This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.
Interventions
DEVICEElectroacupuncture (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.
DEVICESham 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.
Sponsors
Wonkwang University Gwangju Medical Center
Kyunghee University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Urgency and Frequency Score (TUFS) | 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
| Measure | Time frame |
|---|---|
| Adverse events report | intraoperative |
| The Lower urinary track system Outcome Score (LOS) | 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) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blinding Index (BI) | 21 days | Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not. |
Countries
South Korea
Outcome results
None listed