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Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder

This study is not yet open for participant recruitment.
Verified August 2017 by Jung Seunghyun, DongGuk University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03260907
First Posted: August 24, 2017
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Korea Health Industry Development Institute
Information provided by (Responsible Party):
Jung Seunghyun, DongGuk University
  Purpose
The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).

Condition Intervention
Overactive Bladder Menopause Procedure: Electroacupuncture Procedure: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder ; A Multicenter, Randomized, Controlled, Parallel Clinical Trial

Resource links provided by NLM:


Further study details as provided by Jung Seunghyun, DongGuk University:

Primary Outcome Measures:
  • 3-day bladder diary change [ Time Frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) ]
    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 [ Time Frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) ]
    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) [ Time Frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) ]
    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) [ 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) ]
    Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial.


Estimated Enrollment: 98
Anticipated Study Start Date: March 2, 2018
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: October 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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).
Other Name: EA
Experimental: 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.
Procedure: 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 Name: AC

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women over 40 years of age without the possibility of pregnancy
  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:

  1. Diag¬nosed with UTI by urine examination
  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260907


Contacts
Contact: Eun Young Nam, Ph.D +82-31-710-3725 obgyney@naver.com
Contact: Dong Il Kim, Ph.D +82-31-961-9062 obgykdi@naver.com

Locations
Korea, Republic of
Dongguk university Bundang Oriental Hospital Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13601
Contact: Eun Young Nam, Ph.D    +82-31-710-3725    obgyney@naver.com   
Sponsors and Collaborators
DongGuk University
Korea Health Industry Development Institute
  More Information

Responsible Party: Jung Seunghyun, Principal Investigator, DongGuk University
ClinicalTrials.gov Identifier: NCT03260907     History of Changes
Other Study ID Numbers: 2017-0008
First Submitted: August 22, 2017
First Posted: August 24, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung Seunghyun, DongGuk University:
Overactive bladder
menopause
Postmenopausal overactive bladder
Electroacupuncture

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms