The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271607
• Other study ID #: 201405
• Status: Completed
• Phase: N/A
• First received: October 11, 2014
• Last updated: March 11, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Hyperthermia
• Lower Urinary Tract Symptoms
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Frequency or Urgency Adverse Event

Intervention

Device:
• moxibustion
The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Center, Korean Medicine Hospital, Pusan National University	Yangsa	Kyungsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27. — View 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. — View 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/s11136-013-0 — View 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. Review. — View 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 a-blocker treatment in patients with BPH: the ADDITION study. Urology. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overactive bladder-validated 8-questions	This is to measure how the patients have been bothered by OAB.	4 weeks	No
Secondary	Overactive bladder symptom scores	self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.	4, 8 weeks	No
Secondary	The skin temperature of CV4, SP6 and LR3	this is to establish the foundation of researching moxibustion-therapy mechanism.	4, 8 weeks	No