BPHNCT02051036
Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study
A study testing Moxibustion in people with BPH and Benign Prostatic Hyperplasia, run by JUNGNAM KWON at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
- What is being tested?
- Moxibustion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Clinical Research Center, Korean Medicine Hospital, Pusan National University
Yangsa, Kyungsangnamdo, 626-770
About this study
Official title: A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome
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).
Read the 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.
- Conditions
- BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Lower Urinary Tract Symptom
- Being tested
- Moxibustion
- Keywords
- moxibustion
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | A series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH. Receives: Procedure: Moxibustion |
| Waiting | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
International prostate symptom score (IPSS) at 4 weeks
Measured: four weeks after randomization
Secondary outcomes (8)
Patient's global impression of change (PGIC)
Measured: visit 2,3,4,5,6,7,8, 9 in experimental group, visit 8,9 in control group
Maximum flow rate by uroflowmetry (Qmax)
Measured: Baseline and 12 weeks after randomization (both group)
Post-voiding residual urine in bladder (PVR)
Measured: Baseline and 12 weeks after randomization
Changing Process and Persistence of International Prostate Symptom Score (IPSS)
Measured: 2 weeks, 12 weeks after randomization
recruitment rate
Measured: 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)
Measured: 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.
Measured: after four weeks, after 12 weeks
adverse events
patients will be asked if adverse effects have developed
Measured: visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- JUNGNAM KWON
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JUNGNAM KWON, Korean Medicine Hospital of Pusan National University
- Investigators
- Jung Nam Kwon, PhD, Principal investigator, Korean Medicine Hospital, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051036
- Sponsor's protocol ID
- NC1307
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2014
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26656981
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Effectiveness and Safety of Moxibustion for Benign Prostate Hyperplasia With Lower Urinary Tract Syndrome
- ClinicalTrials.gov ID
- NCT02051036
- Acronym / sponsor ID
- NC1307
- Conditions
- BPH, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Lower Urinary Tract Symptom
- Keywords
- moxibustion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- JUNGNAM KWONUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Procedure: MoxibustionA series of moxibustion sessions within four weeks from the baseline with concurrent conventional medications for BPH. |
| Waiting | No intervention | –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). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxibustionIn 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. | Procedure or surgery | Moxibustion |
Primary outcome
International prostate symptom score (IPSS) at 4 weeks
Time frame: four weeks after randomization
8 secondary outcomes
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
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
retention rate
Time frame: after four weeks, after 12 weeks
adverse events
Time frame: visit 1,2,3,4,5,6,7,8,9 in experimental group ; visit 1,8,9 in control group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 26656981Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Nam Kwon, PhD principal investigator
Korean Medicine Hospital, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion in people with BPH and Benign Prostatic Hyperplasia, run by JUNGNAM KWON at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International prostate symptom score (IPSS) at 4 weeks (time frame: four weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.