Overactive BladderNCT02271607
The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients
A study testing moxibustion in people with Overactive Bladder and Hyperthermia, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
Trial summary
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event
- What is being tested?
- moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- malignancy
- obstructive disease of urinary tract
- cystocele, vaginocele or rectocele
- urinary tract infection finding on urine analysis
- diabetic mellitus
- sensory disturbance
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsa, Kyungsangnamdo, 626-770
About this study
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
This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.
Read the 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.
- Conditions
- Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event, Lower Urinary Tract Symptoms
- Being tested
- moxibustion
- Keywords
- moxibustion
- Medical subject headings
- Urinary Bladder, Overactive, Hyperthermia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxibustionDevice
Also called moxa pillar
The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.
| Study group | Role | What they receive |
|---|---|---|
| moxibustion | Experimental | A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks. Receives: Device: moxibustion |
| waiting | No intervention | Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive bladder-validated 8-questions
This is to measure how the patients have been bothered by OAB.
Measured: 4 weeks
Secondary outcomes (2)
Overactive bladder symptom scores
self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.
Measured: 4, 8 weeks
The skin temperature of CV4, SP6 and LR3
this is to establish the foundation of researching moxibustion-therapy mechanism.
Measured: 4, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JUNGNAM KWON, Korean Medicine Hospital of Pusan National University
- Investigators
- Jung Nam Kwon, PhD, Study chair, Korean Medicine Hospital, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271607
- Sponsor's protocol ID
- 201405
- Status last verified
- Mar 2016
- First submitted
- 11 Oct 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20374659Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27.
PubMed 23606872Guo 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.
PubMed 24904204Jeong 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.
PubMed 23715806Takeda 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.
PubMed 23953605Lee 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.
PubMed 30142847
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02271607
- Acronym / sponsor ID
- 201405
- Conditions
- Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event, Lower Urinary Tract Symptoms
- Keywords
- moxibustion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moxibustion | Experimental | Device: moxibustionA 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- malignancy
- obstructive disease of urinary tract
- cystocele, vaginocele or rectocele
- urinary tract infection finding on urine analysis
- diabetic mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moxibustionAlso: moxa pillarThe treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used. | Device | moxibustion |
Primary outcome
Overactive bladder-validated 8-questions
Time frame: 4 weeks
This is to measure how the patients have been bothered by OAB.
2 secondary outcomes
Overactive bladder symptom scores
Time frame: 4, 8 weeks
The skin temperature of CV4, SP6 and LR3
Time frame: 4, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Results publication: PubMed 20374659Lee 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 publication: PubMed 23606872Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27.
- Results publication: PubMed 24904204Guo 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 publication: PubMed 23715806Jeong 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 publication: PubMed 23953605Takeda 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.
- Derived from this study: PubMed 30142847Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Nam Kwon, PhD study chair
Korean Medicine Hospital, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moxibustion in people with Overactive Bladder and Hyperthermia, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive bladder-validated 8-questions (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271607, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.