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

DongGuk University

Status: Unknown

Conditions: Menopause; Overactive Bladder

Treatments: Procedure: Electroacupuncture; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03260907

2017-0008

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups

Electroacupuncture

Experimental group

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.

Treatment:

Procedure: Electroacupuncture

Acupuncture

Experimental group

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.

Treatment:

Procedure: Acupuncture