Effectiveness and Safety of Moxibustion Therapy for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Korean Medicine Hospital of Pusan National University
Sponsor:
Information provided by (Responsible Party):
JUNGNAM KWON, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier:
NCT02051036
First received: January 26, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

This randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on benign prostate hyperplasia(BPH) patients with moderate to severe lower urinary tract symptoms(LUTS).


Condition Intervention
Moxibustion
BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Lower Urinary Tract Symptom
Procedure: Moxibustion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome

Resource links provided by NLM:


Further study details as provided by Korean Medicine Hospital of Pusan National University:

Primary Outcome Measures:
  • International prostate symptom score (IPSS) at 4 weeks [ Time Frame: four weeks after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's global impression of change (PGIC) [ Time Frame: four weeks, 12 weeks after randomization (both group), every visit (active group only) ] [ Designated as safety issue: No ]
  • The Short Form (36) Health Survey (SF-36) [ Time Frame: basline, four weeks, 12 weeks after randomization (both group). two weeks after ramdomization (active group) ] [ Designated as safety issue: No ]
  • Maximum flow rate by uroflowmetry (Qmax) [ Time Frame: Baseline and 12 weeks after randomization (both group) ] [ Designated as safety issue: No ]
  • Post-voiding residual urine in bladder (PVR) [ Time Frame: Baseline and 12 weeks after randomization ] [ Designated as safety issue: No ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxibustion
A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH.
Procedure: Moxibustion

In the moxibustion treatment group, 5 moxibustion points (bilateral SP6, LV3 and unilateral CV4) will be heated with indirect moxibustion (KangHwa, Korea).

The moxa pillars will be removed when the patient feel hotness and require to remove them.

The moxibustion will be conducted repeatedly unless patients feel the sense of heat up to seven times per session.

No Intervention: Waiting
Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 4 weeks while receiving other conventional managements for BPH. After 4 weeks, if participants choose to try the moxibustion treatment, the active acupuncture treatment will be provided for 4 weeks (2 sessions/week).

Detailed Description:

Patients who diagnosed as BPH with moderate to severe LUTS aged 20 to 80 years old will be divided into two groups, one is moxibustion plus conventional therapy group and the other is conventional therapy group.

Patients who belong to moxibustion plus conventional therapy group will be treated moxibustion for eight times by a Korean Medicine doctor with conventional therapy by a urologist.

Patients who belong to conventional therapy group will be treated with conventional therapy only, and they can receive moxibustion therapy after the clinical trial is finished.

IPSS, post void residual volume (PVR) and peak urine flow (Qmax) will be checked to evaluate the effectiveness and safety.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male patients diagnosed benign prostate hyperplasia aged from 20 to 80 years
  2. greater than or equal to eight score on IPSS
  3. submit written consent
  4. who can understand and answer IPSS.

Exclusion Criteria:

  1. prostate or bladder malignancy
  2. received herbal medication for lower urinary tract symptoms within 1 week
  3. history of brain disease could cause urinary difficulty
  4. having problems on answering IPSS due to cognitive impairment.
  5. signs of acute urinary tract infection
  6. Diabetic mellitus
  7. Neurogenic bladder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051036

Contacts
Contact: Minjoo Kang, BcS 82553605907 syblkmj@hanmail.net

Locations
Korea, Republic of
National Clinical Research Center, Korean Medicine Hospital, Pusan National University Not yet recruiting
Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770
Contact: Dong Jin Kim, BcS    82553605902    djkim085@gmail.com   
Principal Investigator: Jung Nam Kwon, PhD         
Sponsors and Collaborators
JUNGNAM KWON
Investigators
Principal Investigator: Jung Nam Kwon, PhD Korean Medicine Hospital, Pusan National University
  More Information

No publications provided

Responsible Party: JUNGNAM KWON, Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02051036     History of Changes
Other Study ID Numbers: NC1307
Study First Received: January 26, 2014
Last Updated: February 4, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Hyperplasia
Hypertrophy
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
Prostatic Diseases
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014