Effect of Electroacupuncture on Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Electroacupuncture (EA) group

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.

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type DEVICE

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.

Sham Electroacupuncture (SA) group

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.

Group Type SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type DEVICE

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.

Interventions

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Electroacupuncture

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.

Intervention Type DEVICE

Sham 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.

Intervention Type DEVICE

Other Intervention Names

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EA SA

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No