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Completed

NCT Number: NCT02271607

The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

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

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Key information

Conditions

Overactive Bladder Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heat Stress Disorders Hyperthermia Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Frequency or Urgency Adverse Event Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Yangsa, Kyungsangnamdo, 626-770, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moxibustion

Device

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

Primary outcomes

  1. Overactive bladder-validated 8-questions

    Time frame: 4 weeks

    This is to measure how the patients have been bothered by OAB.

Secondary outcomes

  1. Overactive bladder symptom scores

    Time frame: 4, 8 weeks

    self-administered questionnaire about daytime frequency, nighttime frequency, urgency and urgency incontinence.

  2. The skin temperature of CV4, SP6 and LR3

    Time frame: 4, 8 weeks

    this is to establish the foundation of researching moxibustion-therapy mechanism.

Sponsors and collaborators

Lead sponsor

Korean Medicine Hospital of Pusan National University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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