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

April 7, 2019 updated by: JUNGNAM KWON

A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyungsangnamdo
      • Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770
        • National Clinical Research Center, Korean Medicine Hospital, Pusan National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International prostate symptom score (IPSS) at 4 weeks
Time Frame: four weeks after randomization
four weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group
Maximum flow rate by uroflowmetry (Qmax)
Time Frame: Baseline and 12 weeks after randomization (both group)
Baseline and 12 weeks after randomization (both group)
Post-voiding residual urine in bladder (PVR)
Time Frame: Baseline and 12 weeks after randomization
Baseline and 12 weeks after randomization
Changing Process and Persistence of International Prostate Symptom Score (IPSS)
Time Frame: 2 weeks, 12 weeks after randomization
2 weeks, 12 weeks after randomization
recruitment rate
Time Frame: 31-December-2015
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)
after 12 weeks
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.
after four weeks, after 12 weeks
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
visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JUNGNAM KWON

Investigators

  • Principal Investigator: Jung Nam Kwon, PhD, Korean Medicine Hospital, Pusan National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC1307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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