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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Lower Urinary Tract Symptom, BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy

Intervention / Treatment
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* Procedure: Moxibustion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion<br>A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH. | Procedure: Moxibustion<br>* 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.<br>|
| No Intervention: Waiting<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's global impression of change (PGIC) |  | visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group | 
| Maximum flow rate by uroflowmetry (Qmax) |  | Baseline and 12 weeks after randomization (both group) | 
| Post-voiding residual urine in bladder (PVR) |  | Baseline and 12 weeks after randomization | 
| Changing Process and Persistence of International Prostate Symptom Score (IPSS) |  | 2 weeks, 12 weeks after randomization | 
| recruitment rate |  | 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) | 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. | after four weeks, after 12 weeks | 
| adverse events | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxibustion