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NCT Number: NCT02051036

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

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).

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Key information

Conditions

BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptom Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

20 year–80 year

Sex eligibility

Male

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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients aged 20-80 years diagnosed with BPH with a prostate size over 20 gm
  • greater than or equal to eight score on IPSS
  • submit written consent
  • who can understand and answer IPSS.

Exclusion criteria

  • prostate or bladder malignancy
  • received herbal medication for lower urinary tract symptoms within 1 week
  • history of brain disease could cause urinary difficulty
  • having problems on answering IPSS due to cognitive impairment.
  • signs of acute urinary tract infection
  • Diabetic mellitus
  • Neurogenic bladder

Treatment and study plan

Moxibustion

Procedure

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.

Primary outcomes

  1. International prostate symptom score (IPSS) at 4 weeks

    Time frame: four weeks after randomization

Secondary outcomes

  1. 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

  2. Maximum flow rate by uroflowmetry (Qmax)

    Time frame: Baseline and 12 weeks after randomization (both group)

  3. Post-voiding residual urine in bladder (PVR)

    Time frame: Baseline and 12 weeks after randomization

  4. Changing Process and Persistence of International Prostate Symptom Score (IPSS)

    Time frame: 2 weeks, 12 weeks after randomization

  5. recruitment rate

    Time frame: 31-December-2015

  6. 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)

  7. 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.

  8. 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

Sponsors and collaborators

Lead sponsor

JUNGNAM KWON

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Apr 9, 2019

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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