Benign Prostatic HyperplasiaNCT04802252
A Diagnostic Study of Abnormal Acoustic Waves in Modern Pulse in Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Pulse diagnosis is one of the traditional diagnostic methods of traditional Chinese medicine, which is of great significance in the process of disease diagnosis.Pulse diagnosis is the diagnosis of disease by touching the pulse of the radial artery at the wrist. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia, Radial Artery
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Jun 2022
- Phase
- Observational
- 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Middle-aged and older men with benign prostatic hyperplasia \& middle-aged and older men without benign prostatic hyperplasia
Who may be able to join
- Test group:
- From March 2020 to June 2021, patients of Chinese Medicine outpatient department, ward and physical examination were continuously recruited in the First Affiliated Hospital of Shandong First Medical University;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Comprehensive evaluation of symptoms, signs and ultrasound examination, meeting the diagnostic criteria of BPH in middle-aged and elderly male patients;
- Ages ranged from 50 to 80 years, and vital signs were stable;
- Patients with informed consent to accept this pulse collection;
Show all 12Show fewer
- Control group:
- From March 2020 to June 2021, patients of Chinese Medicine outpatient department, ward and physical examination were continuously recruited in the First Affiliated Hospital of Shandong First Medical University ;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Symptoms, signs and ultrasonography were evaluated comprehensively, and middle-aged and elderly men with BPH disease were clearly excluded;
- Ages ranged from 50 to 80 years, and vital signs were stable;
- Patients with informed consent to accept this pulse collection;
Who cannot join
- Test group:
- Those who have a serious illness and sit for less than 10 minutes in a quiet state;
- Symptoms, signs and ultrasonography were evaluated comprehensively, and middle-aged and elderly men with BPH disease were clearly excluded;
- Patients with severe infectious diseases;
- Fanguan pulse, oblique flying pulse, etc. who are not easy to collect pulse;
- Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
Show all 18Show fewer
- Patients with Parkinson's or other limb tremors;
- Those who has not signed an informed consent form;
- Patients with atrial fibrillation.
- Control group:
- Those who have a serious illness and sit for less than 10 minutes in a quiet state;
- Comprehensive evaluation of symptoms, signs and ultrasound examination, meeting the diagnostic criteria of BPH in middle-aged and elderly male patients；
- Patients with severe infectious diseases;
- Fanguan pulse, oblique flying pulse, etc. who are not easy to collect pulse;
- Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
- Patients with Parkinson's or other limb tremors;
- Those who has not signed an informed consent form;
- Patients with atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
Lili M Cao, PH.D, qykyc309@163.com
Lucheng Song, PH.D
About this study
Pulse diagnosis is one of the traditional diagnostic methods of traditional Chinese medicine, which is of great significance in the process of disease diagnosis.Pulse diagnosis is the diagnosis of disease by touching the pulse of the radial artery at the wrist. Different diseases reflect different pulse characteristics.What we've found in long-term clinical observation is that patients with benign prostatic hyperplasia have something different in their pulse,the abnormal pulse we called "astringent pulse".There is no modern physiologic and pathological description on the occurrence of "astringent pulse" in traditional pulse science, so we study it from acoustics perspective.Our team thinks that every beat of the heart produces a vibration, which produces sound waves，the sound waves travel through the blood and eventually reflect off the arterial walls.When an organ(such as the prostate)，develops hyperplasia, local blood flow changes,the flow of blood, which should be laminar, changes and becomes turbulent，the conduction of sound waves in turbulence is disordered，so we end up with pulse features that are different from normal people that are reflected on the arterial wall.
We have previously studied the pulse characteristics of chronic gastritis, coronary heart disease, cirrhosis and some other diseases，different pulse sounds were collected and analyzed using an independently developed Acoustic Pulse Detection System，the ideal results have been obtained.We found that most of the abnormal sound waves were between 20Hz and 500Hz, so we classified this sound wave as low frequency and audible sound wave.Based on the above analysis, this study will use the acoustic pulse detection system to collect the pulse images of patients with benign prostatic hyperplasia(BPH).We expected to collect the pulse waves of 62 patients and 62 relatively healthy people without BPH, and use Fourier transform, wavelet analysis and other analysis methods to study the characteristics of the collected sound waves, and observe the pulse characteristics of BPH disease.Then diagnostic tests were carried out to calculate the sensitivity and specificity of the acoustic pulse detection system in the diagnosis of BPH.
This experiment will further verify the effectiveness of pulse diagnosis of diseases, and finally lay a foundation for the development of pulse diagnostic instrument can diagnose a variety of diseases.
- Conditions
- Benign Prostatic Hyperplasia, Radial Artery
- Keywords
- Benign prostatic hyperplasia, Sound Waves, Radial Artery, Diagnostic test
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 62 patients with benign prostatic hyperplasia in the experimental group | The pulse sound waves of three parts and five layers of each of the two hands of 62 patients with benign prostatic hyperplasia were collected by acoustic pulse detection system. | |
| 62 relatively healthy men without benign prostatic hyperplasia in the control group | The pulse sound waves of three parts and five layers of each of the two hands of 62 relatively healthy men without benign prostatic hyperplasia were collected by acoustic pulse detection system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristic sound waves extracted from radial artery of patients with benign prostatic hyperplasia and relatively healthy men without benign prostatic hyperplasia are distinguished.
This characteristic sound wave can distinguish patients with benign prostatic hyperplasia from relatively healthy men without benign prostatic hyperplasia.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lucheng Song, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802252
- Sponsor's protocol ID
- SFUYIN-04
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Foo KT. What is a disease? What is the disease clinical benign prostatic hyperplasia (BPH)? World J Urol. 2019 Jul;37(7):1293-1296. doi: 10.1007/s00345-019-02691-0. Epub 2019 Feb 25.
PubMed 30805683Descazeaud A, Robert G, Delongchamps NB, Cornu JN, Saussine C, Haillot O, Devonec M, Fourmarier M, Ballereau C, Lukacs B, Dumonceau O, Azzouzi AR, Faix A, Desgrandchamps F, de la Taille A; Comite des troubles mictionnels de l'homme de l'association francaise d'urologie. [Initial assessment, follow-up and treatment of lower urinary tract symptoms related to benign prostatic hyperplasia: guidelines of the LUTS committee of the French Urological Association]. Prog Urol. 2012 Dec;22(16):977-88. doi: 10.1016/j.purol.2012.10.001. Epub 2012 Nov 6. French.
PubMed 23178093Van Asseldonk B, Barkin J, Elterman DS. Medical therapy for benign prostatic hyperplasia: a review. Can J Urol. 2015 Oct;22 Suppl 1:7-17.
PubMed 26497339Lima CB, Angrimani DSR, Flores RB, Vannucchi CI. Endocrine, prostatic vascular, and proapoptotic changes in dogs with benign prostatic hyperplasia treated medically or surgically. Domest Anim Endocrinol. 2021 Apr;75:106601. doi: 10.1016/j.domaniend.2020.106601. Epub 2020 Nov 23.
PubMed 33333452Egan KB. The Epidemiology of Benign Prostatic Hyperplasia Associated with Lower Urinary Tract Symptoms: Prevalence and Incident Rates. Urol Clin North Am. 2016 Aug;43(3):289-97. doi: 10.1016/j.ucl.2016.04.001.
PubMed 27476122Thaler L, Goodale MA. Echolocation in humans: an overview. Wiley Interdiscip Rev Cogn Sci. 2016 Nov;7(6):382-393. doi: 10.1002/wcs.1408. Epub 2016 Aug 19.
PubMed 27538733Bilton K, Hammer L, Zaslawski C. Contemporary Chinese pulse diagnosis: a modern interpretation of an ancient and traditional method. J Acupunct Meridian Stud. 2013 Oct;6(5):227-33. doi: 10.1016/j.jams.2013.04.002. Epub 2013 Apr 24.
PubMed 24139459Wang D, Zhang D, Lu G. An Optimal Pulse System Design by Multichannel Sensors Fusion. IEEE J Biomed Health Inform. 2016 Mar;20(2):450-9. doi: 10.1109/JBHI.2015.2392132. Epub 2015 Jan 15.
PubMed 25608317
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Study of Abnormal Acoustic Waves in Modern Pulse in Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04802252
- Acronym / sponsor ID
- SFUYIN-04
- Conditions
- Benign Prostatic Hyperplasia, Radial Artery
- Keywords
- Benign prostatic hyperplasia, Sound Waves, Radial Artery, Diagnostic test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 17 Mar 2021 (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.
Pulse diagnosis is one of the traditional diagnostic methods of traditional Chinese medicine, which is of great significance in the process of disease diagnosis.Pulse diagnosis is the diagnosis of disease by touching the pulse of the radial artery at the wrist. Different diseases reflect different pulse characteristics.What we've found in long-term clinical observation is that patients with benign prostatic hyperplasia have something different in their pulse,the abnormal pulse we called "astringent pulse".There is no modern physiologic and pathological description on the occurrence of "astringent pulse" in traditional pulse science, so we study it from acoustics perspective.Our team thinks that every beat of the heart produces a vibration, which produces sound waves，the sound waves travel through the blood and eventually reflect off the arterial walls.When an organ(such as the prostate)，develops hyperplasia, local blood flow changes,the flow of blood, which should be laminar, changes and becomes turbulent，the conduction of sound waves in turbulence is disordered，so we end up with pulse features that are different from normal people that are reflected on the arterial wall.
We have previously studied the pulse characteristics of chronic gastritis, coronary heart disease, cirrhosis and some other diseases，different pulse sounds were collected and analyzed using an independently developed Acoustic Pulse Detection System，the ideal results have been obtained.We found that most of the abnormal sound waves were between 20Hz and 500Hz, so we classified this sound wave as low frequency and audible sound wave.Based on the above analysis, this study will use the acoustic pulse detection system to collect the pulse images of patients with benign prostatic hyperplasia(BPH).We expected to collect the pulse waves of 62 patients and 62 relatively healthy people without BPH, and use Fourier transform, wavelet analysis and other analysis methods to study the characteristics of the collected sound waves, and observe the pulse characteristics of BPH disease.Then diagnostic tests were carried out to calculate the sensitivity and specificity of the acoustic pulse detection system in the diagnosis of BPH.
This experiment will further verify the effectiveness of pulse diagnosis of diseases, and finally lay a foundation for the development of pulse diagnostic instrument can diagnose a variety of diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 62 patients with benign prostatic hyperplasia in the experimental group | – | –The pulse sound waves of three parts and five layers of each of the two hands of 62 patients with benign prostatic hyperplasia were collected by acoustic pulse detection system. |
| 62 relatively healthy men without benign prostatic hyperplasia in the control group | – | –The pulse sound waves of three parts and five layers of each of the two hands of 62 relatively healthy men without benign prostatic hyperplasia were collected by acoustic pulse detection system. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Middle-aged and older men with benign prostatic hyperplasia \& middle-aged and older men without benign prostatic hyperplasia
Key inclusion criteria (12 listed)
- From March 2020 to June 2021, patients of Chinese Medicine outpatient department, ward and physical examination were continuously recruited in the First Affiliated Hospital of Shandong First Medical University;
- Research site: The First Affiliated Hospital of Shandong First Medical University;
- Comprehensive evaluation of symptoms, signs and ultrasound examination, meeting the diagnostic criteria of BPH in middle-aged and elderly male patients;
- Ages ranged from 50 to 80 years, and vital signs were stable;
- Patients with informed consent to accept this pulse collection;
Key exclusion criteria (18 listed)
- Those who have a serious illness and sit for less than 10 minutes in a quiet state;
- Symptoms, signs and ultrasonography were evaluated comprehensively, and middle-aged and elderly men with BPH disease were clearly excluded;
- Patients with severe infectious diseases;
- Fanguan pulse, oblique flying pulse, etc. who are not easy to collect pulse;
- Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The characteristic sound waves extracted from radial artery of patients with benign prostatic hyperplasia and relatively healthy men without benign prostatic hyperplasia are distinguished.
Time frame: 30 minutes
This characteristic sound wave can distinguish patients with benign prostatic hyperplasia from relatively healthy men without benign prostatic hyperplasia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 30805683Foo KT. What is a disease? What is the disease clinical benign prostatic hyperplasia (BPH)? World J Urol. 2019 Jul;37(7):1293-1296. doi: 10.1007/s00345-019-02691-0. Epub 2019 Feb 25.
- Background: PubMed 23178093Descazeaud A, Robert G, Delongchamps NB, Cornu JN, Saussine C, Haillot O, Devonec M, Fourmarier M, Ballereau C, Lukacs B, Dumonceau O, Azzouzi AR, Faix A, Desgrandchamps F, de la Taille A; Comite des troubles mictionnels de l'homme de l'association francaise d'urologie. [Initial assessment, follow-up and treatment of lower urinary tract symptoms related to benign prostatic hyperplasia: guidelines of the LUTS committee of the French Urological Association]. Prog Urol. 2012 Dec;22(16):977-88. doi: 10.1016/j.purol.2012.10.001. Epub 2012 Nov 6. French.
- Background: PubMed 26497339Van Asseldonk B, Barkin J, Elterman DS. Medical therapy for benign prostatic hyperplasia: a review. Can J Urol. 2015 Oct;22 Suppl 1:7-17.
- Background: PubMed 33333452Lima CB, Angrimani DSR, Flores RB, Vannucchi CI. Endocrine, prostatic vascular, and proapoptotic changes in dogs with benign prostatic hyperplasia treated medically or surgically. Domest Anim Endocrinol. 2021 Apr;75:106601. doi: 10.1016/j.domaniend.2020.106601. Epub 2020 Nov 23.
- Background: PubMed 27476122Egan KB. The Epidemiology of Benign Prostatic Hyperplasia Associated with Lower Urinary Tract Symptoms: Prevalence and Incident Rates. Urol Clin North Am. 2016 Aug;43(3):289-97. doi: 10.1016/j.ucl.2016.04.001.
- Background: PubMed 27538733Thaler L, Goodale MA. Echolocation in humans: an overview. Wiley Interdiscip Rev Cogn Sci. 2016 Nov;7(6):382-393. doi: 10.1002/wcs.1408. Epub 2016 Aug 19.
- Background: PubMed 24139459Bilton K, Hammer L, Zaslawski C. Contemporary Chinese pulse diagnosis: a modern interpretation of an ancient and traditional method. J Acupunct Meridian Stud. 2013 Oct;6(5):227-33. doi: 10.1016/j.jams.2013.04.002. Epub 2013 Apr 24.
- Background: PubMed 25608317Wang D, Zhang D, Lu G. An Optimal Pulse System Design by Multichannel Sensors Fusion. IEEE J Biomed Health Inform. 2016 Mar;20(2):450-9. doi: 10.1109/JBHI.2015.2392132. Epub 2015 Jan 15.
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
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.
Lucheng Song, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
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 12 inclusion and 18 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lucheng Song, Doctor (+8613589089003, lucheng.s@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristic sound waves extracted from radial artery of patients with benign prostatic hyperplasia and relatively healthy men without benign prostatic hyperplasia are distinguished. (time frame: 30 minutes). 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 NCT04802252, which also lists 8 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 17 Mar 2021.