The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

Study Overview
=================
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.

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

Conditions
-----------------
Overactive Bladder, Hyperthermia, Urinary Frequency or Urgency Adverse Event, Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Device: moxibustion


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moxibustion<br>A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks. | Device: moxibustion<br>* The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.<br>* Other names: moxa pillar;|
| No Intervention: waiting<br>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 | 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 | self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence. | 4, 8 weeks | 
| The skin temperature of CV4, SP6 and LR3 | this is to establish the foundation of researching moxibustion-therapy mechanism. | 4, 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moxibustion