Clinical trial to evaluate efficacy and safety of Electroacupuncture and Acupuncture in Postmenopausal Women with overactive bladder

The requested reference [dad7e44da6af212dea959801e6b64b5cc6980c2f] no longer exists in our database. It has been replaced by the current reference: [4262e9377fe36e531703a7bc975649e1c1359b9b]

Authors
Category Primary study
Registry of TrialsKorean Clinical Trials Database
Year 2019
INTERVENTION: Medical Device : For the EA and AC groups, disposable, sterilized, filiform needles (diameter 0.25 mm, length 40 mm; Dong‐Bang Acupuncture Inc., Seoul, Korea) will be inserted into the skin at the following acupoints: unilaterally at CV3, CV4, and GV20, bilaterally at KI3 and SP6. When inserting at CV3, the needling direction will be toward CV2. The needles will be inserted to a depth of between 5 and 30 mm, and the acupuncture needles will be manipulated to achieve de qi and retained for 20 min. In the EA group, electrical stimulation will be performed simultaneously during the retaining period. An electric acupuncture device (CellMac STN‐330, Stratek Co., Republic of Korea) will be connected to the CV3‐CV4 and KI3‐SP6 acupoints and deliver stimulation with a 2 Hz or 16Hz frequency, a maximum intensity below the threshold. Electrical stimulation will be delivered at an intensity that the participant can notice but will still feel comfortable with. CONDITION: Diseases of The genitoruinary system PRIMARY OUTCOME: the average number of micturitions per 24 hour SECONDARY OUTCOME: 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). Korean version of King’s Health Questionnaire Overactive bladder symptom score INCLUSION CRITERIA: 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.
Epistemonikos ID: 388c2cda676091392a23dccdb4402674f42bf8e6
First added on: Dec 20, 2022