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The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

Primary Purpose

Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
moxibustion
Sponsored by
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring moxibustion

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

moxibustion

waiting

Arm Description

A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks.

Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group.

Outcomes

Primary Outcome Measures

Overactive bladder-validated 8-questions
This is to measure how the patients have been bothered by OAB.

Secondary Outcome Measures

Overactive bladder symptom scores
self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.
The skin temperature of CV4, SP6 and LR3
this is to establish the foundation of researching moxibustion-therapy mechanism.

Full Information

First Posted
October 11, 2014
Last Updated
March 11, 2016
Sponsor
Korean Medicine Hospital of Pusan National University
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1. Study Identification

Unique Protocol Identification Number
NCT02271607
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korean Medicine Hospital of Pusan National University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event, Lower Urinary Tract Symptoms
Keywords
moxibustion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moxibustion
Arm Type
Experimental
Arm Description
A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks.
Arm Title
waiting
Arm Type
No Intervention
Arm Description
Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group.
Intervention Type
Device
Intervention Name(s)
moxibustion
Other Intervention Name(s)
moxa pillar
Intervention Description
The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.
Primary Outcome Measure Information:
Title
Overactive bladder-validated 8-questions
Description
This is to measure how the patients have been bothered by OAB.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Overactive bladder symptom scores
Description
self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.
Time Frame
4, 8 weeks
Title
The skin temperature of CV4, SP6 and LR3
Description
this is to establish the foundation of researching moxibustion-therapy mechanism.
Time Frame
4, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged from 20 to 75 years old submit written consent no deficit to notify the hotness promptly and exactly diagnosed with overactive bladder suffering the OAB symptoms during greater than or equal to 3 months Exclusion Criteria: malignancy obstructive disease of urinary tract cystocele, vaginocele or rectocele urinary tract infection finding on urine analysis diabetic mellitus sensory disturbance pregnancy, possibility of pregnancy or planning to pregnancy problems to communication due to any medical problem such as cognitive dysfunction getting other treatment of either Traditional Korean Medicine or conventional medicine for overactive bladder psychiatric disorder or severe systemic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Nam Kwon, PhD
Organizational Affiliation
Korean Medicine Hospital, Pusan National University
Official's Role
Study Chair
Facility Information:
Facility Name
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
City
Yangsa
State/Province
Kyungsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20374659
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.
Results Reference
result
PubMed Identifier
23606872
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.
Results Reference
result
PubMed Identifier
24904204
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.
Results Reference
result
PubMed Identifier
23715806
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.
Results Reference
result
PubMed Identifier
23953605
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.
Results Reference
result
PubMed Identifier
30142847
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. Erratum In: Medicine (Baltimore). 2018 Oct;97(42):e12952.
Results Reference
derived

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The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

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