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Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02051036
First Posted: January 31, 2014
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JUNGNAM KWON, Korean Medicine Hospital of Pusan National University
  Purpose
This study aims to explore the feasibility of moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostate hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 JUNGNAM KWON, Korean Medicine Hospital of Pusan National University:

Primary Outcome Measures:
  • International prostate symptom score (IPSS) at 4 weeks [ Time Frame: four weeks after randomization ]

Secondary Outcome Measures:
  • Patient's global impression of change (PGIC) [ Time Frame: visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group ]
  • 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) ]
  • Maximum flow rate by uroflowmetry (Qmax) [ Time Frame: Baseline and 12 weeks after randomization (both group) ]
  • Post-voiding residual urine in bladder (PVR) [ Time Frame: Baseline and 12 weeks after randomization ]
  • Changing Process and Persistence of International Prostate Symptom Score (IPSS) [ Time Frame: 2 weeks, 12 weeks after randomization ]
  • recruitment rate [ Time Frame: 31-December-2015 ]
  • compliance rate [ Time Frame: after 12 weeks ]
    the attendance rate for treatment phase in integrative group, and for three major assessments (baseline, visit 9 and visit 10)

  • retention rate [ Time Frame: after four weeks, after 12 weeks ]
    the ratio of 1) the number of patients who attend at the primary outcome assessment after four weeks versus the number of total participants, 2) the number of patients who attend the final assessment after 12 weeks versus the number of total participants, 3) the number of patients who returned the frequency-volume chart (FVC) versus the number of total participants.

  • adverse events [ Time Frame: visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group ]
    patients will be asked if adverse effects have developed


Enrollment: 25
Study Start Date: February 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male patients aged 20-80 years diagnosed with BPH with a prostate size over 20 gm
  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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051036


Locations
Korea, Republic of
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770
Sponsors and Collaborators
JUNGNAM KWON
Investigators
Principal Investigator: Jung Nam Kwon, PhD Korean Medicine Hospital, Pusan National University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JUNGNAM KWON, Professor, Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT02051036     History of Changes
Other Study ID Numbers: NC1307
First Submitted: January 26, 2014
First Posted: January 31, 2014
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by JUNGNAM KWON, Korean Medicine Hospital of Pusan National University:
moxibustion

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