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The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

K

Korean Medicine Hospital of Pusan National University

Status

Completed

Conditions

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

Treatments

Device: moxibustion

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.

Full 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.

Enrollment

24 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

24 participants in 2 patient groups

moxibustion
Experimental group
Description:
A series of moxibustion sessions within four weeks from the baseline followed by observation period of four weeks.
Treatment:
Device: moxibustion
waiting
No Intervention group
Description:
Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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