The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

March 11, 2016 updated by: JUNGNAM KWON, Korean Medicine Hospital of Pusan National University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyungsangnamdo
      • Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770
        • National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: moxibustion
A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks.
Device: moxibustion
The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.
Other Names:
  • moxa pillar
NO_INTERVENTION: waiting
Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder-validated 8-questions
Time Frame: 4 weeks
This is to measure how the patients have been bothered by OAB.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder symptom scores
Time Frame: 4, 8 weeks
self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.
4, 8 weeks
The skin temperature of CV4, SP6 and LR3
Time Frame: 4, 8 weeks
this is to establish the foundation of researching moxibustion-therapy mechanism.
4, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Medicine Hospital of Pusan National University

Investigators

  • Study Chair: Jung Nam Kwon, PhD, Korean Medicine Hospital, Pusan National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (ESTIMATE)

October 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overactive Bladder

Clinical Trials on moxibustion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe