Clinical trial NCT02051036: Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study
Official title: A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Lower Urinary Tract Symptom
Keywords: moxibustion
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International prostate symptom score (IPSS) at 4 weeks
timeFrame: four weeks after randomization
Secondary outcomes:
measure: Patient's global impression of change (PGIC)
timeFrame: visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group
measure: Maximum flow rate by uroflowmetry (Qmax)
timeFrame: Baseline and 12 weeks after randomization (both group)
measure: Post-voiding residual urine in bladder (PVR)
timeFrame: Baseline and 12 weeks after randomization
measure: Changing Process and Persistence of International Prostate Symptom Score (IPSS)
timeFrame: 2 weeks, 12 weeks after randomization
measure: recruitment rate
timeFrame: 31-December-2015
measure: compliance rate
timeFrame: after 12 weeks
measure: retention rate
timeFrame: after four weeks, after 12 weeks
measure: adverse events
timeFrame: visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group
Other outcomes:
Locations:
city: Yangsa
country: Korea, Republic of
facility: National Clinical Research Center, Korean Medicine Hospital, Pusan National University
state: Kyungsangnamdo
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Jung Nam Kwon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HY, Nam JK, Lee SD, Lee DH, Han JY, Yun YJ, Lee JH, Park HL, Park SH, Kwon JN. Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial. BMJ Open. 2015 Dec 11;5(12):e008338. doi: 10.1136/bmjopen-2015-008338.