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Effectiveness and Safety of Thread Embedding Acupuncture in Postmenopausal Women with Overactive Bladder; A Pilot Study

Not Applicable
Recruiting
Conditions
Diseases of the genitourinary system
Registration Number
KCT0007892
Lead Sponsor
Dongguk University Gyeongju Campus
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
20
Inclusion Criteria

• Women over 40 years old who were not pregnant.
• Those with amenorrhea for at least one year and no history of hormone replacement therapy in the last six months.
• Those with frequent and urgent urination lasting more than three months.
• Those who met the diagnostic criteria for OAB and had a total score of three or more in the Korean version of OABSS (Overactive Bladder Symptom Score).
• Those with an average urinary frequency of eight or more times a day and urinary urgency as defined by the URS (Urgency Rating Scale) as two or more points in the bladder diary or UUI (Urgent Urinary Incontinence) in a three-day bladder diary over a one-week screening period, or both.
• Those who agreed with this clinical study after sufficient explanation.

Exclusion Criteria

• Those diagnosed with UTI (Urinary Tract Infection) by a urine examination.
• Those with stress urinary incontinence without OAB symptoms.
• Those suspected of urinary dysfunction due to neurological damage.
• Those with a history of cystocele, uterine prolapse or similar diseases.
• Those with a history of obstructive uropathy conditions, such as urolithiasis or urinary tract tumors.
• Those with a history of surgery in urethra or bladder.
• Those with a history of urinary tract malignancies.
• Those with a history of neurological or psychiatric disease.
• Those with an artificial pacemaker or ICD (Implantable Cardioverter-defibrillator) in the chest.
• Those having experienced hypersensitivity or any other side effects after acupuncture treatment.
• Those having been involved in other clinical trials in the last three months.
• Those having taken a treatment drug that may affect bladder function within one month after the commencement of this trial.
• Those with insufficient literacy to write study documents.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
the number of micturitions per 24 hours
Secondary Outcome Measures
NameTimeMethod
the daytime and nocturnal micturitions per 24 hours, the total number of urinary urgency for three days, and the total number of UUI for three days, OABSS, KHQ
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