The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

Not Applicable

Completed

• Conditions: Hyperthermia; Urinary Frequency or Urgency Adverse Event; Lower Urinary Tract Symptoms; Overactive Bladder
• Interventions: Device: moxibustion

• Registration Number: NCT02271607
• Lead Sponsor: Korean Medicine Hospital of Pusan National University

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-11
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overactive bladder-validated 8-questions	4 weeks	This is to measure how the patients have been bothered by OAB.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Clinical Research Center, Korean Medicine Hospital, Pusan National University; 🇰🇷 Yangsa, Kyungsangnamdo, Korea, Republic of