Effect of Electroacupuncture on Benign Prostatic Hyperplasia

Last updated: July 17, 2024
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Enuresis

Bladder Disorders

Treatment

Sham electroacupuncture

Electroacupuncture

Clinical Study ID

NCT05585450
2022-203-KY
  • Ages 40-80
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Post-void residual urine volume (PVR) ≥150 mL;

  2. Acute urinary retention or catheterization for outflow obstruction within the 3months (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 symptomaticurinary 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 specificmedication usage in the previous two weeks unless a stable 5α-reductase inhibitorusage of over three months;

  6. Severe lung, heart, liver, kidney, metabolic, or mental illness, coagulationdysfunction, or with obvious cognitive dysfunction;

  7. Installed cardiac pacemaker, allergy to metal, severe fear of acupuncture orunbearable to the stimulation of EA.

Study Design

Total Participants: 306
Treatment Group(s): 2
Primary Treatment: Sham electroacupuncture
Phase:
Study Start date:
March 09, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 100053
    China

    Active - Recruiting

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