Back to resultsEffect of Electroacupuncture on Benign Prostatic Hyperplasia (EABPH)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham electroacupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring acupuncture, randomized controlled trial, lower urinary tract symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electroacupuncture (EA) group
Sham Electroacupuncture (SA) group
Arm 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.
Participants in the SA group will receive treatment at bilateral sham BL32, BL33, BL35, and SP6. Sham BL32, in the area of 1 cun (≈20mm) horizontally outside BL32; Sham BL33, in the area of 1 cun (≈20mm) horizontally outside BL33; Sham BL35, 1 cun (≈20mm) 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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The change from baseline in the total score of IPSS
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.
The proportion of participants with at least 30% reduction in the total score of 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.
The proportion of participants with at least 50% reduction in the total score of 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.
The change from baseline in the voiding and storage subscale scores of IPSS
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.
The change from baseline in the number of nocturia
Participants will be asked: During the last month, how many times did you most typically get up to urinate from the time you went to bed at night until the time you got up in the morning?
The change from baseline in the quality of life (QOL) item of IPSS
Participants will be asked the question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The response categorized into 7 degrees scoring 0 to 6, respectively: 0 (delighted), 1 (pleased), 2 (mostly satisfied), 3 (mixed about equally satisfied and dissatisfied), 5 (mostly dissatisfied), 5 (unhappy), and 6 (terrible).
The change from baseline in the BPH Impact Index (BPH-II)
The BPH-II measures the interference of LUTS in patients' mental health and activity. The total score of BPH-II ranges from 0 to 13, with higher scores indicating poorer quality of life.
The change from baseline in the International Index of Erectile Function 5 (IIEF-5)
The IIEF-5 is a valid and reliable instrument for detecting treatment effects in patients with erection dysfunction, ranging from 1 to 25, with lower scores indicating more severe dysfunction.
The change from baseline in the hours of undisturbed sleep (HUS)
HUS is defined as the duration from falling asleep till awake in the morning, or till the first nocturia if any.
The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the volume of prostate
The prostate volume will be measured by transabdominal ultrasound.
The change from baseline in the post-void residual urine volume
The post-void residual urine volume will be measured by transabdominal ultrasound.
The change from baseline in the urinary peak and average flow rate
The urinary peak and average flow rate will be measured by uroflowmetry.
The proportion of responders per the Patient Global Index of Improvement (PGI-I)
The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse".
Full Information
NCT ID
NCT05585450
First Posted
October 13, 2022
Last Updated
September 27, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05585450
Brief Title
Effect of Electroacupuncture on Benign Prostatic Hyperplasia
Acronym
EABPH
Official Title
Effect of Electroacupuncture on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to assess the efficacy and safety of electroacupuncture among men with benign prostatic hyperplasia (BPH), compared with sham electroacupuncture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
acupuncture, randomized controlled trial, lower urinary tract symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroacupuncture (EA) group
Arm Type
Experimental
Arm 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.
Arm Title
Sham Electroacupuncture (SA) group
Arm Type
Sham Comparator
Arm Description
Participants in the SA group will receive treatment at bilateral sham BL32, BL33, BL35, and SP6.
Sham BL32, in the area of 1 cun (≈20mm) horizontally outside BL32; Sham BL33, in the area of 1 cun (≈20mm) horizontally outside BL33; Sham BL35, 1 cun (≈20mm) 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.
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
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
Intervention Name(s)
Sham electroacupuncture
Other Intervention Name(s)
SA
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
Description
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.
Time Frame
week 8
Title
The proportion of participants with at least 30% reduction in the total score of International Prostate Symptom Score (IPSS) from baseline
Description
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.
Time Frame
week 20
Secondary Outcome Measure Information:
Title
The change from baseline in the total score of IPSS
Description
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.
Time Frame
weeks 4, 8, 12, 20, 32
Title
The proportion of participants with at least 30% reduction in the total score of IPSS from baseline
Description
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.
Time Frame
weeks 4, 12, 32
Title
The proportion of participants with at least 50% reduction in the total score of IPSS from baseline
Description
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.
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the voiding and storage subscale scores of IPSS
Description
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.
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the number of nocturia
Description
Participants will be asked: During the last month, how many times did you most typically get up to urinate from the time you went to bed at night until the time you got up in the morning?
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the quality of life (QOL) item of IPSS
Description
Participants will be asked the question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? The response categorized into 7 degrees scoring 0 to 6, respectively: 0 (delighted), 1 (pleased), 2 (mostly satisfied), 3 (mixed about equally satisfied and dissatisfied), 5 (mostly dissatisfied), 5 (unhappy), and 6 (terrible).
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the BPH Impact Index (BPH-II)
Description
The BPH-II measures the interference of LUTS in patients' mental health and activity. The total score of BPH-II ranges from 0 to 13, with higher scores indicating poorer quality of life.
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the International Index of Erectile Function 5 (IIEF-5)
Description
The IIEF-5 is a valid and reliable instrument for detecting treatment effects in patients with erection dysfunction, ranging from 1 to 25, with lower scores indicating more severe dysfunction.
Time Frame
weeks 8, 20, 32
Title
The change from baseline in the hours of undisturbed sleep (HUS)
Description
HUS is defined as the duration from falling asleep till awake in the morning, or till the first nocturia if any.
Time Frame
weeks 4, 8, 12, 20, 32
Title
The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Description
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Time Frame
weeks 8, 20, 32
Title
The change from baseline in the volume of prostate
Description
The prostate volume will be measured by transabdominal ultrasound.
Time Frame
week 8
Title
The change from baseline in the post-void residual urine volume
Description
The post-void residual urine volume will be measured by transabdominal ultrasound.
Time Frame
week 8
Title
The change from baseline in the urinary peak and average flow rate
Description
The urinary peak and average flow rate will be measured by uroflowmetry.
Time Frame
week 8
Title
The proportion of responders per the Patient Global Index of Improvement (PGI-I)
Description
The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse".
Time Frame
weeks 8, 20, 32
Other Pre-specified Outcome Measures:
Title
Expectance assessment
Description
Participants will be asked: How do you expect your lower urinary tract symptoms (LUTS) will be in two months?
Time Frame
Baseline assessment (week 0)
Title
Assessment of belief in acupuncture
Description
Participants will be asked the question: Do you think your BPH may be helped by acupuncture? Time Frame: Baseline assessment (week 0) and week 8 Participants will be asked the question: Do you think your BPH may be helped by electroacupuncture?
Time Frame
Baseline assessment (week 0) and week 8
Title
Blinding assessment
Description
Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks?
Time Frame
Within 5 minutes after either treatment at week 8
Title
Safety assessment
Description
Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.
Time Frame
Throughout the trial
Title
Adherence assessment
Description
Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.
Time Frame
weeks 1-8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu
Phone
+861088002331
Email
zhishunjournal@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Zhu
Phone
+8618851182160
Email
julius.zhu@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Phone
+861088002331
Email
zhishunjournal@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data and data dictionary will be available with the publication until six months after publication.
A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal.
Researchers whose proposal has been approved will sign a data access agreement.
IPD Sharing Time Frame
The data will be available with the publication until six months after publication.
IPD Sharing 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.
Learn more about this trial
Effect of Electroacupuncture on Benign Prostatic Hyperplasia
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