Back to resultsEfficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder
Primary Purpose
Overactive Bladder, Menopause
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electroacupuncture
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, menopause, Postmenopausal overactive bladder, Electroacupuncture
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dongguk university Bundang Oriental Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Electroacupuncture
Acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The overactive bladder symptom score (OABSS) change
The OABSS consists of four questions regarding OAB symptoms; day¬time frequency, nocturia, urgency, and UUI. The sum of the four scores runs between 0 and 15.
The King's Health Questionnaire (KHQ)
The KHQ is a urine questionnaire that can assess the severity of urination symptoms and evaluate the impact of urination symptoms on quality of life. This questionnaire is known to have reliability and validity in measuring the quality of life of patients with incontinence. The 10 domains from the KHQ evaluated are general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity.
Adverse events (AEs)
Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial.
Full Information
NCT ID
NCT03260907
First Posted
August 22, 2017
Last Updated
August 24, 2017
Sponsor
DongGuk University
Collaborators
Korea Health Industry Development Institute
1. Study Identification
Unique Protocol Identification Number
NCT03260907
Brief Title
Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder
Official Title
Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder ; A Multicenter, Randomized, Controlled, Parallel Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2018 (Anticipated)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DongGuk University
Collaborators
Korea Health Industry Development Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).
Detailed Description
The investigators targeted the patients of menopausal women with OAB. After treatment in 2 groups - electroacupuncture treatment and acupuncture treatment - the investigators will compare the improvement of the urinary symptoms and the quality of life, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Menopause
Keywords
Overactive bladder, menopause, Postmenopausal overactive bladder, Electroacupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
AC
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-day bladder diary change
Description
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.
Time Frame
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Secondary Outcome Measure Information:
Title
The overactive bladder symptom score (OABSS) change
Description
The OABSS consists of four questions regarding OAB symptoms; day¬time frequency, nocturia, urgency, and UUI. The sum of the four scores runs between 0 and 15.
Time Frame
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Title
The King's Health Questionnaire (KHQ)
Description
The KHQ is a urine questionnaire that can assess the severity of urination symptoms and evaluate the impact of urination symptoms on quality of life. This questionnaire is known to have reliability and validity in measuring the quality of life of patients with incontinence. The 10 domains from the KHQ evaluated are general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity.
Time Frame
at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Title
Adverse events (AEs)
Description
Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial.
Time Frame
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Young Nam, Ph.D
Phone
+82-31-710-3725
Email
obgyney@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Il Kim, Ph.D
Phone
+82-31-961-9062
Email
obgykdi@naver.com
Facility Information:
Facility Name
Dongguk university Bundang Oriental Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13601
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Young Nam, Ph.D
Phone
+82-31-710-3725
Email
obgyney@naver.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30219086
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder
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