The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

NCT02271607 | Completed DMC

• 1 other identifier: 201405
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

moxibustion

Outcome Measures

Primary Outcomes (1)

• Overactive bladder-validated 8-questions

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

  4 weeks

Secondary Outcomes (2)

• Overactive bladder symptom scores

  4, 8 weeks

• The skin temperature of CV4, SP6 and LR3

  4, 8 weeks

Study Arms (2)

moxibustion

EXPERIMENTAL

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

Device: moxibustion

waiting

NO INTERVENTION

Waiting period of four weeks followed by moxibustion therapy sessions on the same way with moxibustion group.

Interventions

moxibustion DEVICE

The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.

Also known as: moxa pillar

moxibustion

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead

Study Sites (1)

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

Yangsa, Kyungsangnamdo, 626-770, South Korea

Location

Related Publications (6)

• Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130.

  PMID: 20374659 RESULT

• Chiu JH. How does moxibustion possibly work? Evid Based Complement Alternat Med. 2013;2013:198584. doi: 10.1155/2013/198584. Epub 2013 Mar 27.

  PMID: 23606872 RESULT

• Guo ZF, Liu Y, Hu GH, Liu H, Xu YF. Transcutaneous electrical nerve stimulation in the treatment of patients with poststroke urinary incontinence. Clin Interv Aging. 2014 May 23;9:851-6. doi: 10.2147/CIA.S61084. eCollection 2014.

  PMID: 24904204 RESULT

• Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.

  PMID: 23715806 RESULT

• Takeda M, Nishizawa O, Gotoh M, Yoshida M, Takahashi S, Masumori N. Clinical efficacy and safety of imidafenacin as add-on treatment for persistent overactive bladder symptoms despite alpha-blocker treatment in patients with BPH: the ADDITION study. Urology. 2013 Oct;82(4):887-93. doi: 10.1016/j.urology.2013.05.008. Epub 2013 Aug 14.

  PMID: 23953605 RESULT

• Lee HY, Yun YJ, Choi JY, Hong JW, Lee I, Park SH, Kwon JN. Effectiveness and safety of moxibustion for alleviating symptoms of overactive bladder: A prospective, randomized controlled, crossover-design, pilot study. Medicine (Baltimore). 2018 Aug;97(34):e12016. doi: 10.1097/MD.0000000000012016.

  PMID: 30142847 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Hyperthermia; Lower Urinary Tract Symptoms

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Jung Nam Kwon, PhD

  Korean Medicine Hospital, Pusan National University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

KR (1)