Benign Prostatic HyperplasiaBPH/LUTSNCT05288621
Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms
A study testing electroacupuncture in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electroacupuncture at "Four Sacral Points" for Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms: A Randomized Controlled Trial
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.
- Being tested
- electroacupuncture
- Keywords
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, electroacupuncture, four sacral points
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
Also called Acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture at'four sacral points' | Experimental | 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. Receives: Device: electroacupuncture |
| conventional electroacupuncture | Active comparator | 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. Receives: Device: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: week4; week 8
Secondary outcomes (4)
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.
Measured: week4; week 8
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.
Measured: week4; week 8
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.
Measured: week4; week 8
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.
Measured: week4; week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Zhou, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Jie Zhou, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288621
- Sponsor's protocol ID
- 3rdZhejiangCMU
- Acronym
- BPH/LUTS
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12559262Abrams 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.
PubMed 33315535
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture at "Four Sacral Points" for Benigh Prosatic Hyperplasia/Lower Urinary Tract Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05288621
- Acronym / sponsor ID
- BPH/LUTS / 3rdZhejiangCMU
- Keywords
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, electroacupuncture, four sacral points
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture at'four sacral points' | Experimental | Device: electroacupunctureThe 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. |
| conventional electroacupuncture | Active comparator | Device: electroacupunctureThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroacupunctureAlso: AcupunctureFor'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. | Device | conventional electroacupuncture, electroacupuncture at'four sacral points' |
Primary outcome
the Change From Baseline in the International Prostate Symptom Score (IPSS)
Time frame: week4; week 8
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%.
4 secondary outcomes
the Change From Baseline in the Overactive Bladder Symptom Score(OABSS)
Time frame: week4; week 8
the Change From Baseline in the Quality of Life Score(QOL)
Time frame: week4; week 8
the Change From Baseline in the Prostate Volume(PV)
Time frame: week4; week 8
the Change From Baseline in the Post-Void Residual(PVR)
Time frame: week4; week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Results publication: PubMed 12559262Abrams 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 publication: PubMed 33315535Abrams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Zhou principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zhou (15968895450, zhoujie0111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Change From Baseline in the International Prostate Symptom Score (IPSS) (time frame: week4; week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288621, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.