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Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS)

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
The Third Affiliated hospital of Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, electroacupuncture, four sacral points

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of BPH in accordance with the criteria of the Chinese Urological Diagnosis and Treatment Guidelines 2014 edition.
  • Male patients aged 40-80 years.
  • Not on any 5a-reductase inhibitor, a1 receptor blocker or traditional Chinese medicine in the past two weeks.
  • International Prostate Symptom Score (IPSS) scores range from 1 to 19.
  • Family members or patients give informed consent and sign informed consent.

Exclusion Criteria:

  • Patients with recurrent urinary tract infections.
  • Patients with neurogenic bladder and urethral stricture, bladder tumor and prostate cancer.
  • Patients with benign prostatic obstruction who have failed invasive treatment.
  • Patients with serious cardiovascular and cerebrovascular diseases, hematopoietic system and other primary diseases and mental disorders.
  • Patients who are participating in other clinical trials or who are participating in other clinical trials within one month.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    electroacupuncture at'four sacral points'

    conventional electroacupuncture

    Arm Description

    The participants in the electroacupuncture at'four sacral points'group will receive treatment that consists of 8 acupuncture sessions over an 4-week period after baseline (2 sessions in each week), each for 30 minutes. Hua Tuo brand disposable acupunctureneedles (size 0.40 × 100mm) and electronic needle therapy instrument SDZ-IIB will be used.The device will be set at a frequency of 2.0 Hz, continuous wave and a moderate intensity the patient can tolerate. Electrostimulation will be performed for 30 min during each treatment. BL30 (Baihuanshu )(both sides and BL35 (Huiyang )(both sides), were selected as acupoints protocol.BL30 is located on either side of the sacrococcygeal joint, approximately 1 cm from the joint. BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.

    The participants in the conventional electroacupuncture group will select RN3 (Zhongji), CV4 (Guanyuan), and ST28 (Shuidao, both sides), KL3 (Taixi).A needle measuring 0.25×40 mm will be inserted perpendicularly to a depth of 25- 40 mm to RN3, CV4 and ST28 and 0.5 cun to KL3 to induce a local sensation (distention or sourness).Subsequently, the electrodes from the SDZ-IIB electroacupuncture device will be connected to the needles at these points, with the anode connected to ST28 and RN3, the cathode connected to ST28 and CV4. The protocol includes the same duration, frequency of sessions and the parameter setting of electroacupuncture as for the'four sacral points'treatment.

    Outcomes

    Primary Outcome Measures

    the Change From Baseline in the International Prostate Symptom Score (IPSS)
    IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it iswidely used in clinical practice and research to determine the severity of lower urinary tractsymptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency,weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5(almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.Significant effect was defined as most of the major symptoms and signs disappeared, and the score decreased between 60% and 89%. Effective is that the main symptoms and signs disappear partially, and the score decreases by 30%-59%.

    Secondary Outcome Measures

    the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)
    OABSS is a valid self-assessment questionnaire, four questions were set according to OAB syndrome to determine the severity of OAB, which include daytime and nighttime urination frequency, urgency, urge incontinence. Score range is 0-15, with higher scores indicating increasing symptom severity.
    the Change From Baseline in the Quality of Life Score(QOL)
    The QOL score understands the subjective perception of BPH patients about the impact of their current symptoms on their quality of life and is divided into 7 levels, corresponding to a score of 0-6, with the higher the score the lower the patient's quality of life, mainly indicating the extent to which the patient suffers from LUTS.
    the Change From Baseline in the Prostate Volume(PV)
    Transabdominal urinary system B ultrasound examination, can understand whether the upper urinary tract water, expansion, prostate size, shape, whether hyperplastic glands burst into the bladder, the extent of burst, burst range, whether there is abnormal nodular echo, etc.. Then the anterior and posterior diameters, left and right diameters and upper and lower diameters of the prostate were measured respectively, and then the prostate volume was calculated according to the formula.
    the Change From Baseline in the Post-Void Residual(PVR)
    The measurement of PVR is basically the same as that of prostate volume. The three data of anterior and posterior diameters, upper and lower diameters and left and right diameters of residual urine were measured, and the residual urine volume was calculated according to the formula.

    Full Information

    First Posted
    March 11, 2022
    Last Updated
    March 22, 2022
    Sponsor
    The Third Affiliated hospital of Zhejiang Chinese Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05288621
    Brief Title
    Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms
    Acronym
    BPH/LUTS
    Official Title
    Electroacupuncture at "Four Sacral Points" for Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Third Affiliated hospital of Zhejiang Chinese Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Benign prostatic hyperplasia (BPH) is a common condition in aging men that is frequently associated with troublesome lower urinary tract symptoms (LUTS) which can be divided into storage phase symptoms (urinary frequency, urinary urgency, increased nocturia, urinary incontinence, etc.), voiding phase symptoms (interruption of urination, thinning of the urine line, straining to urinate, etc.), and post-void symptoms (incomplete sensation of urination, dribbling after urination, etc.).BPH is prevalent in as many as 40% of men in their fifties and 90% of men in their eighties.Yet, few effective therapiesare available for treating BPH/LUTS. Acupuncture may be an effective treatment option for BPH/LUTS.However, effects of acupuncture on BPH/LUTS remain uncertain because of the small sample sizes or other methodological limitations. The objective of this randomized,conventional electroacupuncture-controlled trial is to assess the effectiveness of electroacupuncture at'four sacral points'for relieving symptoms of BPH/LUTS. The results will provide a robust conclusion with a highlevel of evidence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
    Keywords
    Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, electroacupuncture, four sacral points

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    electroacupuncture at'four sacral points'
    Arm Type
    Experimental
    Arm Description
    The participants in the electroacupuncture at'four sacral points'group will receive treatment that consists of 8 acupuncture sessions over an 4-week period after baseline (2 sessions in each week), each for 30 minutes. Hua Tuo brand disposable acupunctureneedles (size 0.40 × 100mm) and electronic needle therapy instrument SDZ-IIB will be used.The device will be set at a frequency of 2.0 Hz, continuous wave and a moderate intensity the patient can tolerate. Electrostimulation will be performed for 30 min during each treatment. BL30 (Baihuanshu )(both sides and BL35 (Huiyang )(both sides), were selected as acupoints protocol.BL30 is located on either side of the sacrococcygeal joint, approximately 1 cm from the joint. BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.
    Arm Title
    conventional electroacupuncture
    Arm Type
    Active Comparator
    Arm Description
    The participants in the conventional electroacupuncture group will select RN3 (Zhongji), CV4 (Guanyuan), and ST28 (Shuidao, both sides), KL3 (Taixi).A needle measuring 0.25×40 mm will be inserted perpendicularly to a depth of 25- 40 mm to RN3, CV4 and ST28 and 0.5 cun to KL3 to induce a local sensation (distention or sourness).Subsequently, the electrodes from the SDZ-IIB electroacupuncture device will be connected to the needles at these points, with the anode connected to ST28 and RN3, the cathode connected to ST28 and CV4. The protocol includes the same duration, frequency of sessions and the parameter setting of electroacupuncture as for the'four sacral points'treatment.
    Intervention Type
    Device
    Intervention Name(s)
    electroacupuncture
    Other Intervention Name(s)
    Acupuncture
    Intervention Description
    For'four sacral points'group, Hua Tuo brand disposable acupuncture needles (size 0.40 × 100mm) and electronic needle therapy instrument SDZ-IIB will be used.Bilateral BL30 and BL35, were selected as acupoints protocol. 'Four sacral points'group consists of 8 sessions over an 4-week period after baseline(2 sessions in each week), each for 30minutes. The electroacupuncture will be set at a frequency of 2.0 Hz, continuous wave, a moderate intensity the patient can tolerate and 30 min during each treatment.
    Primary Outcome Measure Information:
    Title
    the Change From Baseline in the International Prostate Symptom Score (IPSS)
    Description
    IPSS is a valid, reliable and sensitive measure for patients with lower urinary tract symptoms; it iswidely used in clinical practice and research to determine the severity of lower urinary tractsymptoms, including incomplete bladder emptying, frequency of urination, intermittency, urgency,weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5(almost always). IPSS score ranges from 0 to 35, with higher score indicating more severe urinary symptoms.Significant effect was defined as most of the major symptoms and signs disappeared, and the score decreased between 60% and 89%. Effective is that the main symptoms and signs disappear partially, and the score decreases by 30%-59%.
    Time Frame
    week4; week 8
    Secondary Outcome Measure Information:
    Title
    the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)
    Description
    OABSS is a valid self-assessment questionnaire, four questions were set according to OAB syndrome to determine the severity of OAB, which include daytime and nighttime urination frequency, urgency, urge incontinence. Score range is 0-15, with higher scores indicating increasing symptom severity.
    Time Frame
    week4; week 8
    Title
    the Change From Baseline in the Quality of Life Score(QOL)
    Description
    The QOL score understands the subjective perception of BPH patients about the impact of their current symptoms on their quality of life and is divided into 7 levels, corresponding to a score of 0-6, with the higher the score the lower the patient's quality of life, mainly indicating the extent to which the patient suffers from LUTS.
    Time Frame
    week4; week 8
    Title
    the Change From Baseline in the Prostate Volume(PV)
    Description
    Transabdominal urinary system B ultrasound examination, can understand whether the upper urinary tract water, expansion, prostate size, shape, whether hyperplastic glands burst into the bladder, the extent of burst, burst range, whether there is abnormal nodular echo, etc.. Then the anterior and posterior diameters, left and right diameters and upper and lower diameters of the prostate were measured respectively, and then the prostate volume was calculated according to the formula.
    Time Frame
    week4; week 8
    Title
    the Change From Baseline in the Post-Void Residual(PVR)
    Description
    The measurement of PVR is basically the same as that of prostate volume. The three data of anterior and posterior diameters, upper and lower diameters and left and right diameters of residual urine were measured, and the residual urine volume was calculated according to the formula.
    Time Frame
    week4; week 8

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    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 criteria of the Chinese Urological Diagnosis and Treatment Guidelines 2014 edition. Male patients aged 40-80 years. Not on any 5a-reductase inhibitor, a1 receptor blocker or traditional Chinese medicine in the past two weeks. International Prostate Symptom Score (IPSS) scores range from 1 to 19. Family members or patients give informed consent and sign informed consent. Exclusion Criteria: Patients with recurrent urinary tract infections. Patients with neurogenic bladder and urethral stricture, bladder tumor and prostate cancer. Patients with benign prostatic obstruction who have failed invasive treatment. Patients with serious cardiovascular and cerebrovascular diseases, hematopoietic system and other primary diseases and mental disorders. Patients who are participating in other clinical trials or who are participating in other clinical trials within one month.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Zhou
    Phone
    15968895450
    Email
    zhoujie0111@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jie Zhou
    Organizational Affiliation
    The Third Affiliated hospital of Zhejiang Chinese Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12559262
    Citation
    Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
    Results Reference
    result
    PubMed Identifier
    33315535
    Citation
    Abrams P. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. Letter. J Urol. 2021 Mar;205(3):938. doi: 10.1097/JU.0000000000001558. Epub 2020 Dec 14. No abstract available.
    Results Reference
    result

    Learn more about this trial

    Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms

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