RecruitingNot ApplicableNCT05585450

Effect of Electroacupuncture on Benign Prostatic Hyperplasia

Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Enrollment

306 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia

Summary

The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.

Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Inclusion Criteria7

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;
Prostate volume ≥20 mL;
Urinary peak flow rate (Qmax) ≤15 mL/s;
Voluntary participation in the trial and signed written informed content.

Exclusion Criteria7

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.);
Previous acupuncture treatment for BPH in the preceding one month, or α-blockers, 5α-reductase inhibitor, muscarinic receptor antagonists, or any other specific medication usage in the previous two weeks unless a stable 5α-reductase inhibitor usage of over three months;
Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.

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Interventions

DEVICEElectroacupuncture

BL32 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.

DEVICESham electroacupuncture

The 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.