Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Acupuncture, Mild and moderate BPH
Brief summary
To evaluate efficacy of BL33 for mild and moderate benign prostatic hyperplasia(BPH).There are trials showing that electroacupuncture on BL33 for mild and moderate BPH is more effective than terazosin. It could reduce the International Prostate Syndrome Score (IPSS) by 6.68±2.84(39.79%),lower urinary symptoms bother of score(BS) and bladder residual urine, and increase maximum urinary flow rate.But the efficacy of BL33 has not been studied. The objective of this study is to evaluate efficacy of BL32 for mild and moderate BPH by comparison with non-acupoint group.
Detailed description
efficacy here means specific effect(or active ingredient) of the point BL33.
Interventions
DEVICEneedle
For the acupoint group,needle on bilateral BL33 60-80mm with a 45°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 50-70 years old * Mild to moderate BPH evaluated by I-PSS * Patients having urinary dysfunction more than 3 months * Patients with stable life signs * no use of α1 receptor blocker, 5α-reductase inhibitor or traditional Chinese medicine for over 1 week * Volunteer to join this research and sign the written informed consent prior to receiving treatment
Exclusion criteria
* Urinary dysfunction caused by gonorrhea or urinary tract infection * Oliguria and anuria caused by urinary calculi, prostate cancer, bladder tumor and acute/chronic renal failure * Urinary dysfunction caused by neurogenic bladder, bladder neck fibrotic and urethral stricture * Failure of invasive therapy for prostatic obstruction * Injured local organs, muscle and nerve caused by pelvic operation or historical trauma * Upper urinary obstruction and hydrocele combined with damaged renal function due to BPH diagnosed by B-ultrasound * Patients who can't stick to treatment because of economic reason, far distance between home and the hospital or difficult walking etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat) | baseline and the 6th week | International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population. |
| Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol). | baseline and the 6th week | International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week | baseline and the 6th week | Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean |
| Change of Bladder Residual Urine at the 6th Week | baseline and the 6th week | Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean |
| Change of International Prostate Symptom Score (IPSS) at the 18th Week | baseline and the 18th week | International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean. |
Countries
China
Participant flow
Recruitment details
We recruited patients from BPH clinic by newspaper advertisements and notices at clinic site.192 participants entered the study and 92 of them were excluded.It is supposed that patients with IPSS less than 20 would be included.But few mild BPH patients came for the study.The including criteria were changed and patients with IPSS≥8 were included.
Pre-assignment details
Diagnosis and assessment were made by an independent urologist who was uninvolved in the treatment process.Baseline assessments included international prostate symptom score (IPSS), postvoid residual urine (PVR) and maximum urinary flow rate (Qmax).
Participants by arm
| Arm | Count |
|---|---|
| Acupoint Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. | 50 |
| Non-acupoint Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.
BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Protocol Violation | 5 | 10 |
Baseline characteristics
| Characteristic | Acupoint | Non-acupoint | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 27 Participants | 53 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 23 Participants | 47 Participants |
| Age Continuous | 64.8 years STANDARD_DEVIATION 7.05 | 65.9 years STANDARD_DEVIATION 6.74 | 65.37 years STANDARD_DEVIATION 6.89 |
| bladder residual urine | 20 ml | 16 ml | 20 ml |
| International Prostate Symptom Score (IPSS) | 20.10 units on a scale STANDARD_DEVIATION 6.52 | 18.76 units on a scale STANDARD_DEVIATION 6.06 | 19.43 units on a scale STANDARD_DEVIATION 6.3 |
| maximum urinary flow rate (Qmax) | 13.04 ml/s STANDARD_DEVIATION 6.73 | 15.93 ml/s STANDARD_DEVIATION 7.33 | 14.51 ml/s STANDARD_DEVIATION 7.15 |
| Region of Enrollment China | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 50 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 2 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol).
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean. And analysis for this outcome measure is based on per-protocol population.
Time frame: baseline and the 6th week
Population: The data analysis of the primary outcome is also based on per-protocol (PP) population as a supportive analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupoint | Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol). | 7.24 units on a scale | Standard Deviation 5.23 |
| Non-acupoint | Change of International Prostate Symptom Score(IPSS) at the 6th Week Compared With Baseline(Per-protocol). | 2.79 units on a scale | Standard Deviation 5.17 |
p-value: <0.0195% CI: [2.07, 6.18]ANCOVA
Primary
Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat)
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),6 week mean minus baseline mean.And analysis for this outcome measure is based on ITT population.
Time frame: baseline and the 6th week
Population: The data analysis of the primary outcome was based on the ITT population(data of all participants who are randomized will be analyzed).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupoint | Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat) | 7.26 units on a scale | Standard Deviation 5.12 |
| Non-acupoint | Change of IPSS at the 6th Week Compared With Baseline(Intention to Treat) | 2.34 units on a scale | Standard Deviation 4.85 |
p-value: <0.0195% CI: [2.67, 6.36]ANCOVA
Secondary
Change of Bladder Residual Urine at the 6th Week
Bladder residual urine was used to assess the bladder function, 6 week mean minus baseline mean
Time frame: baseline and the 6th week
Population: The data analysis of the secondary outcome was based on the ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupoint | Change of Bladder Residual Urine at the 6th Week | 0 ml |
| Non-acupoint | Change of Bladder Residual Urine at the 6th Week | 0 ml |
p-value: >0.0595% CI: [-9.76, 16.44]Wilcoxon (Mann-Whitney)
Secondary
Change of International Prostate Symptom Score (IPSS) at the 18th Week
International Prostate Symptom Score (IPSS) Range:0-35(0 is best，35 is worst, ordinal),18 week mean minus baseline mean.
Time frame: baseline and the 18th week
Population: The data analysis of the secondary outcome was based on the ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupoint | Change of International Prostate Symptom Score (IPSS) at the 18th Week | 5.48 units on a scale | Standard Deviation 5.16 |
| Non-acupoint | Change of International Prostate Symptom Score (IPSS) at the 18th Week | 1.8 units on a scale | Standard Deviation 5.06 |
p-value: <0.0195% CI: [1.36, 5.05]ANCOVA
Secondary
Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week
Maximum urinary flow rate was used to assess the bladder function, 6 week mean minus baseline mean
Time frame: baseline and the 6th week
Population: The data analysis of the secondary outcome was based on the ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupoint | Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week | 0.36 ml/second | Standard Deviation 4.51 |
| Non-acupoint | Change of Maximum Urinary Flow Rate(Qmax)at the 6th Week | 0.98 ml/second | Standard Deviation 4.05 |
p-value: >0.0595% CI: [-1.41, 1.78]ANCOVA