Clinical trial NCT03260907: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Menopause
Keywords: Overactive bladder
menopause
Postmenopausal overactive bladder
Electroacupuncture
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2017-08-24
Enrollment: 98
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 3-day bladder diary change
timeFrame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
Secondary outcomes:
measure: The overactive bladder symptom score (OABSS) change
timeFrame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
measure: The King's Health Questionnaire (KHQ)
timeFrame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
measure: Adverse events (AEs)
timeFrame: 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)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Dongguk university Bundang Oriental Hospital
state: Gyeonggi-do
Study officials:
References:
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.