Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder
NCT ID: NCT03260907
Last Updated: 2017-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
98 participants
INTERVENTIONAL
2018-03-02
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture
The patients in this group received electroacupuncture using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.
Electroacupuncture
The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6\~13.9mA).
Acupuncture
The patients in this group received acupuncture without electric stimulation using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.
Acupuncture
The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used.
Interventions
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Electroacupuncture
The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6\~13.9mA).
Acupuncture
The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a history of amenorrhea for at least 1 year and have no previous history of hormone replacement therapy for the last 6 months
3. With symptoms of urinary frequency and urgency lasting more than three months
4. Who fit the diagnostic criteria for OAB, with a total score more than three points in Korean version overactive bladder symptom score (OABSS)
5. Who have average urinary frequency of more than eight times per day and urgency which is defined as urgency rating scale (URS) on bladder diary is more than two points and/or UUI on 3-day bladder diary during one week screening period
6. Who agree to this clinical study after sufficient explanation
Exclusion Criteria
2. With stress urinary incontinence without symptoms of OAB
3. With suspected of having voiding dys¬function induced by neurological damage
4. With a medical history of cystocele, uterine pro¬lapse or similar
5. With a medical history of obstructive uropathy such as urinary stones and urinary tumors
6. With a surgical history of urethra or bladder
7. With a medical history of malignant tumors of urinary tract
8. With a medical history of neurologic disease or psychi¬atric illness
9. Have an artificial cardiac pacemaker or implantable cardioverter defibrillator in the chest
10. Have experienced a hypersensitivity reaction after an acupuncture treatment, or show any other contraindications;
11. Who participated in another clinical trial within the past three months
12. Who have taken therapeutic drugs that may affect blad¬der function within one month of the start of this study
13. With inadequate literacy to complete study documents
40 Years
FEMALE
Yes
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
DongGuk University
OTHER
Responsible Party
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Jung Seunghyun
Principal Investigator
Locations
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Dongguk university Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Nam EY, Park JY, Jo J, Jung SH, Lim CY, Kim DI. Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial. Trials. 2018 Sep 15;19(1):493. doi: 10.1186/s13063-018-2715-3.
Other Identifiers
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2017-0008
Identifier Type: -
Identifier Source: org_study_id
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