Urinary Incontinence Clinical Trial
Official title:
Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: a Pilot Multicentered, Randomized, Parallel, Sham-controlled Trial
Verified date | June 2017 |
Source | Kyunghee University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.
Status | Completed |
Enrollment | 56 |
Est. completion date | June 1, 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Wonkwang University Gwangju Medical Center | Gwangju | |
Korea, Republic of | Kyung Hee University Korean Medicine Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyunghee University | Wonkwang University Gwangju Medical Center |
Korea, Republic of,
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. — View Citation
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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. Review. — View Citation
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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. — View Citation
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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) | ||
Secondary | 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) | ||
Secondary | The Lower urinary track system Outcome Score (LOS) | at least 15 days (at most 21 days) (at baseline and the end of the treatment) | ||
Secondary | Adverse events report | intraoperative |
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