Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder
1 other identifier
interventional
98
1 country
1
Brief Summary
The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
March 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedAugust 28, 2017
August 1, 2017
8 months
August 22, 2017
August 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3-day bladder diary change
The daytime micturitions per 24 hr, nocturnal micturitions per 24 hr, total count of urgency (sum of urgency epi¬sodes defined as URS ≥ 3 for three days), total urgency score (sum of urgency score for three days), and total count of UUI (sum of UUI episodes for three days) is checked.
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Secondary Outcomes (3)
The overactive bladder symptom score (OABSS) change
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
The King's Health Questionnaire (KHQ)
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Adverse events (AEs)
at baseline, every treatment(12 sessions in 6 weeks, including after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Study Arms (2)
Electroacupuncture
EXPERIMENTALThe 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.
Acupuncture
EXPERIMENTALThe 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Women over 40 years of age without the possibility of pregnancy
- Have a history of amenorrhea for at least 1 year and have no previous history of hormone replacement therapy for the last 6 months
- With symptoms of urinary frequency and urgency lasting more than three months
- Who fit the diagnostic criteria for OAB, with a total score more than three points in Korean version overactive bladder symptom score (OABSS)
- 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
- Who agree to this clinical study after sufficient explanation
You may not qualify if:
- Diag¬nosed with UTI by urine examination
- With stress urinary incontinence without symptoms of OAB
- With suspected of having voiding dys¬function induced by neurological damage
- With a medical history of cystocele, uterine pro¬lapse or similar
- With a medical history of obstructive uropathy such as urinary stones and urinary tumors
- With a surgical history of urethra or bladder
- With a medical history of malignant tumors of urinary tract
- With a medical history of neurologic disease or psychi¬atric illness
- Have an artificial cardiac pacemaker or implantable cardioverter defibrillator in the chest
- Have experienced a hypersensitivity reaction after an acupuncture treatment, or show any other contraindications;
- Who participated in another clinical trial within the past three months
- Who have taken therapeutic drugs that may affect blad¬der function within one month of the start of this study
- With inadequate literacy to complete study documents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DongGuk Universitylead
- Korea Health Industry Development Institutecollaborator
Study Sites (1)
Dongguk university Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, 13601, South Korea
Related Publications (1)
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.
PMID: 30219086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 24, 2017
Study Start
March 2, 2018
Primary Completion
October 31, 2018
Study Completion
December 31, 2018
Last Updated
August 28, 2017
Record last verified: 2017-08