Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Lower Urinary Tract Symptom
Conditions
Keywords
moxibustion
Brief summary
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
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.
Interventions
PROCEDUREMoxibustion
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.
Sponsors
JUNGNAM KWON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International prostate symptom score (IPSS) at 4 weeks | four weeks after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| compliance rate | 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 | 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 | 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 |
| recruitment rate | 31-December-2015 | — |
Countries
South Korea
Outcome results
None listed