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

N/ACompletedNCT02051036

JUNGNAM KWON25 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Lower Urinary Tract Symptom

Interventions

MoxibustionPROCEDURE

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.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Yangsa, Kyungsangnamdo, South Korea

Outcomes

Primary Outcomes

International prostate symptom score (IPSS) at 4 weeks

Time frame: four weeks after randomization

Secondary Outcomes

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

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

the attendance rate for treatment phase in integrative group, and for three major assessments (baseline, visit 9 and visit 10)

Time frame: after 12 weeks

retention rate

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.

Time frame: after four weeks, after 12 weeks

adverse events

Data from ClinicalTrials.gov

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