Clinical trial to evaluate efficacy and safety of Electroacupuncture and Acupuncture in Postmenopausal Women with overactive bladder
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003912
- Lead Sponsor
- Dongguk University Ilsan Oriental Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 147
The inclusion criteria for the study will be as follows: (1) women over 40 years of age without the possibility of pregnancy; (2) those who 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) those who have symptoms of urinary frequency and urgency lasting more than 3 months; (4) those who fit the diagnostic criteria for OAB, with a total score of more than 3 points on the Korean version of the Overactive Bladder Symptom Score (OABSS); (5) those who have an average urinary frequency of more than eight times per day and urgency defined by the urgency rating scale (URS) on the bladder diary of more than 2 points and/or urgent urinary incontinence (UUI) on the 3-day bladder diary during a 1-week screening period; (6) those who agree to this clinical study after sufficient explanation.
The exclusion criteria for the study are as follows: (1) diagnosed with UTI by urine examination; (2) having stress urinary incontinence without symptoms of OAB; (3) suspected of having voiding dysfunction induced by neurological damage; (4) a medical history of cystocele, uterine prolapse or similar condition; (5) a medical history of obstructive uropathy such as urinary stones and urinary tumors; (6) a surgical history of urethra or bladder; (7) a medical history of malignant tumors of the urinary tract; (8) a medical history of neurological disease or psychiatric illness; (9) an artificial cardiac pacemaker or implantable cardioverter defibrillator in the chest; (10) having experienced a hypersensitivity reaction after an acupuncture treatment, or showing any other contraindications; (11) having participated in another clinical trial within the past three months; (12) having taken therapeutic drugs that may affect bladder function within one month of the start of this study; (13) having inadequate literacy to complete the study documents.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the average number of micturitions per 24 hour
- Secondary Outcome Measures
Name Time Method Overactive bladder symptom score;Korean version of King’s Health Questionnaire;daytime micturitions per 24 h, nocturnal micturitions per 24 h, total count of urgency (sum of urgency episodes 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).