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).
Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Lower Urinary Tract Symptom
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome|
- International prostate symptom score (IPSS) at 4 weeks [ Time Frame: four weeks after randomization ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- The Short Form (36) Health Survey (SF-36) [ Time Frame: basline, four weeks, 12 weeks after randomization (both group). two weeks after ramdomization (active group) ] [ Designated as safety issue: No ]
- Maximum flow rate by uroflowmetry (Qmax) [ Time Frame: Baseline and 12 weeks after randomization (both group) ] [ Designated as safety issue: No ]
- Post-voiding residual urine in bladder (PVR) [ Time Frame: Baseline and 12 weeks after randomization ] [ Designated as safety issue: No ]
- Changing Process and Persistence of International Prostate Symptom Score (IPSS) [ Time Frame: 2 weeks, 12 weeks after randomization ] [ Designated as safety issue: No ]
- recruitment rate [ Time Frame: 31-December-2015 ] [ Designated as safety issue: No ]
- compliance rate [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]the attendance rate for treatment phase in integrative group, and for three major assessments (baseline, visit 9 and visit 10)
- retention rate [ Time Frame: after four weeks, after 12 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group ] [ Designated as safety issue: No ]patients will be asked if adverse effects have developed
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH.
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.
No Intervention: Waiting
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02051036
|Contact: Minjoo Kang, BcSfirstname.lastname@example.org|
|Korea, Republic of|
|National Clinical Research Center, Korean Medicine Hospital, Pusan National University||Recruiting|
|Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770|
|Contact: Dong Jin Kim, BcS 82553605902 email@example.com|
|Principal Investigator: Jung Nam Kwon, PhD|
|Principal Investigator:||Jung Nam Kwon, PhD||Korean Medicine Hospital, Pusan National University|