Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02051036|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : March 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|BPH Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Lower Urinary Tract Symptom||Procedure: Moxibustion||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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).
- International prostate symptom score (IPSS) at 4 weeks [ Time Frame: four weeks after randomization ]
- 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 ]
- 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) ]
- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051036
|Korea, Republic of|
|National Clinical Research Center, Korean Medicine Hospital, Pusan National University|
|Yangsa, Kyungsangnamdo, Korea, Republic of, 626-770|
|Principal Investigator:||Jung Nam Kwon, PhD||Korean Medicine Hospital, Pusan National University|