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This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.
Patients who diagnosed as overactive bladder aged 20 to 75 years old will be divided into two groups, one is moxibustion-therapy and the other is waiting-list group.
Patients who belong to moxibustion therapy group will be treated moxibustion for 12 times by a Korean Medicine doctor.
Patients who belong to waiting-list group will be prohibited to get any treatment including moxibustion for relieve the symptoms of overactive bladder, and the same moxibustion therapy with moxbiustion-therapy group will be conducted after 4 weeks.
Overactive bladder symptom score (OABSS), overactive bladder-validated 8-question (OAB-V8) will be measured to evaluate the effectiveness.
The number of side effect will be measured to evaluate the safety.
The skin temperature of CV4, SP6 and LR3, and the tympanic temperature will be measured to study treatment mechanism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moxibustion | Experimental | A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks. |
|
| waiting | No Intervention | Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxibustion | Device | The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overactive bladder-validated 8-questions | This is to measure how the patients have been bothered by OAB. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overactive bladder symptom scores | self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence. | 4, 8 weeks |
| The skin temperature of CV4, SP6 and LR3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung Nam Kwon, PhD | Korean Medicine Hospital, Pusan National University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center, Korean Medicine Hospital, Pusan National University | Yangsa | Kyungsangnamdo | 626-770 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20374659 | Result | Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130. | |
| 23606872 | Result | Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D000084462 | Hyperthermia |
| D059411 | Lower Urinary Tract Symptoms |
| 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 |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
this is to establish the foundation of researching moxibustion-therapy mechanism.
| 4, 8 weeks |
| 24904204 | Result | Guo ZF, Liu Y, Hu GH, Liu H, Xu YF. Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. Clin Interv Aging. 2014 May 23;9:851-6. doi: 10.2147/CIA.S61084. eCollection 2014. |
| 23715806 | Result | Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29. |
| 23953605 | Result | Takeda M, Nishizawa O, Gotoh M, Yoshida M, Takahashi S, Masumori N. Clinical efficacy and safety of imidafenacin as add-on treatment for persistent overactive bladder symptoms despite alpha-blocker treatment in patients with BPH: the ADDITION study. Urology. 2013 Oct;82(4):887-93. doi: 10.1016/j.urology.2013.05.008. Epub 2013 Aug 14. |
| 30142847 | Derived | Lee HY, Yun YJ, Choi JY, Hong JW, Lee I, Park SH, Kwon JN. Effectiveness and safety of moxibustion for alleviating symptoms of overactive bladder: A prospective, randomized controlled, crossover-design, pilot study. Medicine (Baltimore). 2018 Aug;97(34):e12016. doi: 10.1097/MD.0000000000012016. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |