Clinical trial NCT02271607: The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients
Official title: A Pilot Study About The Effects of Indirect-Moxibustion on Bladder- Functional Improvement and Symptoms Management in Patients With Overactive Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Hyperthermia
Urinary Frequency or Urgency Adverse Event
Lower Urinary Tract Symptoms
Keywords: moxibustion
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. aged from 20 to 75 years old
2. submit written consent
3. no deficit to notify the hotness promptly and exactly
4. diagnosed with overactive bladder
5. suffering the OAB symptoms during greater than or equal to 3 months

Exclusion Criteria:

1. malignancy
2. obstructive disease of urinary tract
3. cystocele, vaginocele or rectocele
4. urinary tract infection finding on urine analysis
5. diabetic mellitus
6. sensory disturbance
7. pregnancy, possibility of pregnancy or planning to pregnancy
8. problems to communication due to any medical problem such as cognitive dysfunction
9. getting other treatment of either Traditional Korean Medicine or conventional medicine for overactive bladder
10. psychiatric disorder or severe systemic disease.

Primary outcomes:
measure: Overactive bladder-validated 8-questions
timeFrame: 4 weeks
Secondary outcomes:
measure: Overactive bladder symptom scores
timeFrame: 4, 8 weeks
measure: The skin temperature of CV4, SP6 and LR3
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Yangsa
country: Korea, Republic of
facility: National Clinical Research Center, Korean Medicine Hospital, Pusan National University
state: Kyungsangnamdo
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Jung Nam Kwon, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27.
citation: 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.
citation: 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.
citation: 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.
citation: 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.