Clinical trial NCT05585450: Effect of Electroacupuncture on Benign Prostatic Hyperplasia
Official title: Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: acupuncture
randomized controlled trial
lower urinary tract symptoms
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 306
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
timeFrame: week 8
measure: The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
timeFrame: week 20
Secondary outcomes:
measure: The change from baseline in the total score of IPSS
timeFrame: weeks 4, 8, 12, 20, 32
measure: The proportion of participants with at least 30% reduction in the total score of IPSS from baseline
timeFrame: weeks 4, 12, 32
measure: The proportion of participants with at least 50% reduction in the total score of IPSS from baseline
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the voiding and storage subscale scores of IPSS
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the number of nocturia
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the quality of life (QOL) item of IPSS
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the BPH Impact Index (BPH-II)
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the International Index of Erectile Function 5 (IIEF-5)
timeFrame: weeks 8, 20, 32
measure: The change from baseline in the hours of undisturbed sleep (HUS)
timeFrame: weeks 4, 8, 12, 20, 32
measure: The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
timeFrame: weeks 8, 20, 32
measure: The change from baseline in the volume of prostate
timeFrame: week 8
measure: The change from baseline in the post-void residual urine volume
timeFrame: week 8
measure: The change from baseline in the urinary peak and average flow rate
timeFrame: week 8
measure: The proportion of responders per the Patient Global Index of Improvement (PGI-I)
timeFrame: weeks 8, 20, 32
Other outcomes:
measure: Expectance assessment
timeFrame: Baseline assessment (week 0)
measure: Assessment of belief in acupuncture
timeFrame: Baseline assessment (week 0) and week 8
measure: Blinding assessment
timeFrame: Within 5 minutes after either treatment at week 8
measure: Safety assessment
timeFrame: Throughout the trial
measure: Adherence assessment
timeFrame: weeks 1-8
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: PRINCIPAL_INVESTIGATOR
References: