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

Not Applicable

• Conditions: Overactive Bladder; Menopause
• Interventions: Procedure: Electroacupuncture; Procedure: Acupuncture

• Registration Number: NCT03260907
• Lead Sponsor: DongGuk University

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.

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-28
• Study Start: 2018-03-02
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture	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.
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
3-day bladder diary change	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

Name	Time	Method
The King's Health Questionnaire (KHQ)	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.
The overactive bladder symptom score (OABSS) change	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.
Adverse events (AEs)	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.

Trial Locations

Locations (1)

Dongguk university Bundang Oriental Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of