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| ID | Type | Description | Link |
|---|---|---|---|
| KOMCIRB-160215-HR-006 | Other Identifier | IRB of Kyung Hee University Korean Medicine Hospital |
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| Name | Class |
|---|---|
| Wonkwang University | OTHER |
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This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture (EA) group | Experimental |
|
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| Park sham (PS) group | Sham Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture (EA) | Device | The EA group will receive the verum therapies using the following procedures.
The procedure will be repeated 10 times (once a session) within 21 days. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Blinding Index (BI) | Patients will be asked to answer which arm they think they belonged to, assessing that the blinding succeed or not. | 21 days |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Euiju Lee, Ph.D. | Kyunghee University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Gwangju Medical Center | Gwangju | 61729 | South Korea | |||
| Kyung Hee University Korean Medicine Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3790967 | Background | Currie CT. Urinary incontinence after stroke. Br Med J (Clin Res Ed). 1986 Nov 22;293(6558):1322-3. doi: 10.1136/bmj.293.6558.1322-a. No abstract available. | |
| 8446973 | Background | Gelber DA, Good DC, Laven LJ, Verhulst SJ. Causes of urinary incontinence after acute hemispheric stroke. Stroke. 1993 Mar;24(3):378-82. doi: 10.1161/01.str.24.3.378. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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|
|
| Sham electroacupuncture | Device |
The procedure will be repeated 10 times (once a session) within 21 days. |
|
|
| 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 |
| Seoul |
| 156-853 |
| South Korea |
| 10753993 | Background | Brittain KR, Perry SI, Peet SM, Shaw C, Dallosso H, Assassa RP, Williams K, Jagger C, Potter JF, Castleden CM. Prevalence and impact of urinary symptoms among community-dwelling stroke survivors. Stroke. 2000 Apr;31(4):886-91. doi: 10.1161/01.str.31.4.886. |
| 2916918 | Background | Garrett VE, Scott JA, Costich J, Aubrey DL, Gross J. Bladder emptying assessment in stroke patients. Arch Phys Med Rehabil. 1989 Jan;70(1):41-3. |
| 20708280 | Background | Mizrahi EH, Waitzman A, Arad M, Blumstein T, Adunksy A. Bladder management and the functional outcome of elderly ischemic stroke patients. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e125-8. doi: 10.1016/j.archger.2010.07.007. Epub 2010 Aug 12. |
| 11291687 | Background | Mustonen S, Ala-Houhala IO, Tammela TL. Long-term renal dysfunction in patients with acute urinary retention. Scand J Urol Nephrol. 2001 Feb;35(1):44-8. doi: 10.1080/00365590151030804. |
| 11554277 | Background | Curtis LA, Dolan TS, Cespedes RD. Acute urinary retention and urinary incontinence. Emerg Med Clin North Am. 2001 Aug;19(3):591-619. doi: 10.1016/s0733-8627(05)70205-4. |
| 15791633 | Background | Tibaek S, Gard G, Jensen R. Pelvic floor muscle training is effective in women with urinary incontinence after stroke: a randomised, controlled and blinded study. Neurourol Urodyn. 2005;24(4):348-57. doi: 10.1002/nau.20134. |
| 21140719 | Background | Herr-Wilbert IS, Imhof L, Hund-Georgiadis M, Wilbert DM. Assessment-guided therapy of urinary incontinence after stroke. Rehabil Nurs. 2010 Nov-Dec;35(6):248-53. doi: 10.1002/j.2048-7940.2010.tb00055.x. |
| 19678782 | Background | Tong Y, Jia Q, Sun Y, Hou Z, Wang Y. Acupuncture in the treatment of diabetic bladder dysfunction. J Altern Complement Med. 2009 Aug;15(8):905-9. doi: 10.1089/acm.2009.0062. |
| 23834208 | Background | Mehdi Z, Birns J, Bhalla A. Post-stroke urinary incontinence. Int J Clin Pract. 2013 Nov;67(11):1128-37. doi: 10.1111/ijcp.12183. Epub 2013 Jul 8. |
| 23932438 | Background | van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3. |
| 24712917 | Background | Chapple CR, Drake MJ, Van Kerrebroeck P, Cardozo L, Drogendijk T, Klaver M, Van Charldorp K, Hakimi Z, Compion G. Total urgency and frequency score as a measure of urgency and frequency in overactive bladder and storage lower urinary tract symptoms. BJU Int. 2014 May;113(5):696-703. doi: 10.1111/bju.12555. Epub 2014 Feb 20. |
| 16469618 | Background | Abrams P, Avery K, Gardener N, Donovan J; ICIQ Advisory Board. The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006 Mar;175(3 Pt 1):1063-6; discussion 1066. doi: 10.1016/S0022-5347(05)00348-4. |
| 23235974 | Background | Hajebrahimi S, Nourizadeh D, Hamedani R, Pezeshki MZ. Validity and reliability of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and its correlation with urodynamic findings. Urol J. 2012 Fall;9(4):685-90. |
| 21564443 | Background | Kang SG, Park CH, Kim DK, Park JK, Hong SJ, Chung BH, Kim CS, Lee KS, Kim JC, Lee JG. Long-term outcome of tamsulosin for patients with lower urinary tract symptoms according to the treatment response defined by lower urinary tract symptom outcomes score. Int J Clin Pract. 2011 Jun;65(6):691-7. doi: 10.1111/j.1742-1241.2011.02667.x. |
| 15020033 | Background | Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |