The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
Male participants aged between 40 and 80 years;
Lower urinary tract symptoms (LUTS) for at least three months;
IPSS total score ≥8;
Post-void residual urine volume (PVR) ≥150 mL;
Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
Neurogenic lower urinary tract dysfunction; prostatitis; uncontrolled symptomatic urinary tract infections; urethral strictures; bladder diverticula; bladder stones; bladder cancer; history of genitourinary system surgery (prostate, bladder, urethra, etc.);
Parallel
Electroacupuncture
DeviceBL32 and BL33 will be inserted by needles of 0.30×75mm size at an angle of 45°, inward and downward, to the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, to the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm to the depth of 25-30mm. The needles will be lifted, thrust, and twisted evenly three times after insertion to induce the sensation of deqi. The electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hertz (Hz) and an electric current of 2-6.5 milliampere (mA) for BL32, BL33 and BL35, and 0.5 mA-2mA for SP6.
Sham electroacupuncture
DeviceThe four pairs of acupoints will be inserted by needles of 0.30×25mm or 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. The electronic acupuncture apparatus (Yingdi KWD 808I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the four pairs of needles transversally, with a continuous wave of 5 Hz and a minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
The change from baseline in the total score of IPSS
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
The proportion of participants with at least 30% reduction in the total score of IPSS from baseline
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
The proportion of participants with at least 50% reduction in the total score of IPSS from baseline
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
The change from baseline in the voiding and storage subscale scores of IPSS
The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.
Expectance assessment
Participants will be asked: How do you expect your lower urinary tract symptoms (LUTS) will be in two months?
Assessment of belief in acupuncture
Participants will be asked the question: Do you think your BPH may be helped by acupuncture? Time Frame: Baseline assessment (week 0) and week 8 Participants will be asked the question: Do you think your BPH may be helped by electroacupuncture?
Blinding assessment
Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks?
Safety assessment
Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.
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