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

Overactive Bladder Clinical Trial

Official title:

Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder ; A Multicenter, Randomized, Controlled, Parallel Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03260907
• Other study ID #: 2017-0008
• Status: Not yet recruiting
• Phase: N/A
• First received: August 22, 2017
• Last updated: August 24, 2017
• Start date: March 2, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2017
• Source: DongGuk University
• Contact: Eun Young Nam, Ph.D
• Phone: +82-31-710-3725
• Email: obgyney[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Menopause
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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).
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk university Bundang Oriental Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
DongGuk University	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Secondary	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.	at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Secondary	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.	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)