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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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The purpose of this study is to verify the efficacy and safety of electroacupuncture treatment of postmenopausal women with overactive bladder (OAB).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture | Experimental | 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. |
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| Acupuncture | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Procedure | The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6~13.9mA). |
| Measure | Description | Time Frame |
|---|---|---|
| 3-day bladder diary change | 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. | at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) |
| Measure | Description | Time Frame |
|---|---|---|
| The overactive bladder symptom score (OABSS) change | 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. | at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Young Nam, Ph.D | Contact | +82-31-710-3725 | obgyney@naver.com | |
| Dong Il Kim, Ph.D | Contact | +82-31-961-9062 | obgykdi@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk university Bundang Oriental Hospital | Seongnam-si | Gyeonggi-do | 13601 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30219086 | Derived | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
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| Acupuncture | Procedure | The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. |
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| The King's Health Questionnaire (KHQ) |
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. |
| at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation) |
| Adverse events (AEs) | Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial. | 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) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |