Effect of Electroacupuncture on Benign Prostatic Hyperplasia

NCT05585450 | Recruiting

• 1 other identifier: 2022-203-KY
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia

Keywords

acupuncture; randomized controlled trial; lower urinary tract symptoms

Outcome Measures

Primary Outcomes (2)

• The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline

  The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.

  week 8

• The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline

  The IPSS is a valid, reliable, and sensitive measure tool frequently used to evaluate the severity of lower urinary tract symptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining, and nocturia. The score of IPSS ranges from 0 to 35, with scores of 0 to 7 indicating mild symptoms; 8 to 19 indicating moderate symptoms; and 20 to 35 indicating severe symptoms.

  week 20

Secondary Outcomes (14)

• The change from baseline in the total score of IPSS

  weeks 4, 8, 12, 20, 32

• The proportion of participants with at least 30% reduction in the total score of IPSS from baseline

  weeks 4, 12, 32

• The proportion of participants with at least 50% reduction in the total score of IPSS from baseline

  weeks 4, 8, 12, 20, 32

• The change from baseline in the voiding and storage subscale scores of IPSS

  weeks 4, 8, 12, 20, 32

• The change from baseline in the number of nocturia

  weeks 4, 8, 12, 20, 32

Other Outcomes (5)

• Expectance assessment

  Baseline assessment (week 0)

• Assessment of belief in acupuncture

  Baseline assessment (week 0) and week 8

• Blinding assessment

  Within 5 minutes after either treatment at week 8

Study Arms (2)

Electroacupuncture (EA) group

EXPERIMENTAL

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.

Device: Electroacupuncture

Sham Electroacupuncture (SA) group

SHAM COMPARATOR

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.

Device: Sham electroacupuncture

Interventions

Electroacupuncture 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.

Also known as: EA

Electroacupuncture (EA) group

Sham electroacupuncture 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.

Also known as: SA

Sham Electroacupuncture (SA) group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (1)

• Zhu L, Yan Y, Yu J, Liu Y, Sun Y, Chen Y, Fang J, Liu Z. Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a randomised controlled trial. BMJ Open. 2024 Jul 20;14(7):e080743. doi: 10.1136/bmjopen-2023-080743.

  PMID: 39032929 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhishun Liu

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishun Liu

CONTACT

+861088002331; zhishunjournal@163.com

Lili Zhu

CONTACT

+8618851182160; julius.zhu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dean of Acupuncture Department

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: March 9, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.

Locations

CN (1)