Effect of Electroacupuncture on Benign Prostatic Hyperplasia (EABPH)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Electroacupuncture; Device: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05585450

2022-203-KY

Details and patient eligibility

About

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

Enrollment: 306 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of BPH in accordance with the European Association of Urology (EAU) guideline;
2. Male participants aged between 40 and 80 years;
3. Lower urinary tract symptoms (LUTS) for at least three months;
4. IPSS total score ≥8;
5. Prostate volume ≥20 mL;
6. Urinary peak flow rate (Qmax) ≤15 mL/s;
7. Voluntary participation in the trial and signed written informed content.

Exclusion criteria

1. Post-void residual urine volume (PVR) ≥150 mL;
2. Acute urinary retention or catheterization for outflow obstruction within the 3 months (Except for post-surgical disposable catheterization);
3. Prostate cancer or prostate-specific antigen (PSA) level ≥4.0 ng/mL;
4. 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.);
5. 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;
6. Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulation dysfunction, or with obvious cognitive dysfunction;
7. Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture or unbearable to the stimulation of EA.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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306 participants in 2 patient groups

Electroacupuncture (EA) group

Experimental group

Description:

Participants in the EA group will receive treatment at bilateral Bladder Meridian (BL) 32 \[Ciliao\], BL33 \[Zhongliao\], BL35 \[Huiyang\], and Spleen Meridian (SP) 6 \[Sanyinjiao\]. BL32, in the second posterior sacral foramen; BL33, in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; SP6, posterior to the medial border of the tibia, 3 cun (≈60mm) superior to the prominence of the medial malleolus. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks.

Treatment:

Device: Electroacupuncture

Sham Electroacupuncture (SA) group

Sham Comparator group

Description:

Participants in the SA group will receive treatment at bilateral sham BL32, BL33, BL35, and SP6. Sham BL32, in the area of 2 cun (≈40mm) horizontally outside BL32; Sham BL33, in the area of 2 cun (≈40mm) horizontally outside BL33; Sham BL35, 2 cun (≈40mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The treatment will last 30 minutes for each session, 3 sessions per week (ideally every other day) for a succession of 8 weeks.

Treatment:

Device: Sham electroacupuncture