Lower Urinary Tract SymptomsEECPLUTSNCT01815697
Effect of Enhanced External Counterpulsation on Lower Urinary Tract Symptoms
A study testing Enhanced External Counterpulsation in people with Lower Urinary Tract Symptoms, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Enhanced External Counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2018
- 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men over 18 years old;
- provide signed informed consent;
- existence of lower urinary tract symptoms
- agree not to use any lower urinary tract symptoms treatment at least one month;
- suitable for receiving EECP treatment
Who cannot join
- history of long drug abuse;
- pelvic, spine, brain trauma or surgery;
- endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
- Severe infection without effective control；
- lower limbs deep vein thrombosis；
- Large area of ulcerative rash；
- unsuitable for receiving EECP treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat- sen University
Guangzhou, Guangdong, 510080
Weiwei Zhang, PhD, 8620-87334871, zhweiw2@mail.sysu.edu.cn
Chunhua Deng, M. D., 0086-13501519349, dch0313@163.com
About this study
Official title: A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.
Read the detailed description
Patients with benign prostatic hyperplasia and will be randomized into two groups: EECP intervention or not. Lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Enhanced External Counterpulsation
- Keywords
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced External CounterpulsationDevice
Also called EECP
Enhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients will receive 35-36 hours EECP intervention, 1-hour session every day over a 7-week period.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Men with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment Receives: Device: Enhanced External Counterpulsation |
| Control | No intervention | Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
Measured: 7 weeks
Secondary outcomes (2)
Urinary flow rate
Change from baseline in urinary flow rate
Measured: 7 weeks
Endothelial function
Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Sheng Fu,MD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yan Zhang, M. D., Study director, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815697
- Sponsor's protocol ID
- NSFC-81070488
- Acronym
- EECPLUTS
- Status last verified
- Apr 2017
- First submitted
- 19 Mar 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study of Enhanced External Counterpulsation in Patients With Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT01815697
- Acronym / sponsor ID
- EECPLUTS / NSFC-81070488
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia, Urinary Retention, Vascular Endothelium, Counterpulsation, External
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Mar 2013 (estimated)
- 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.
The purpose of this study is to access the effects of Enhanced External Counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.
Detailed description
Patients with benign prostatic hyperplasia and will be randomized into two groups: EECP intervention or not. Lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with benign prostatic hyperplasia are assigned to two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Enhanced External Counterpulsation | Experimental | Device: Enhanced External CounterpulsationMen with benign prostatic hyperplasia receive 35- 36 hours Enhanced External Counterpulsation treatment |
| Control | No intervention | –Men with benign prostatic hyperplasia without Enhanced External Counterpulsation treatment as control |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- men over 18 years old;
- provide signed informed consent;
- existence of lower urinary tract symptoms
- agree not to use any lower urinary tract symptoms treatment at least one month;
- suitable for receiving EECP treatment
Key exclusion criteria (7 listed)
- history of long drug abuse;
- pelvic, spine, brain trauma or surgery;
- endocrine, liver, lung, kidney disease, malignancies, hematological disorders;
- Severe infection without effective control；
- lower limbs deep vein thrombosis；
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 |
|---|---|---|
| Enhanced External CounterpulsationAlso: EECPEnhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients will receive 35-36 hours EECP intervention, 1-hour session every day over a 7-week period. | Device | Enhanced External Counterpulsation |
Primary outcome
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score
Time frame: 7 weeks
2 secondary outcomes
Urinary flow rate
Time frame: 7 weeks
Endothelial function
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- 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.
Yan Zhang, M. D. study director
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced External Counterpulsation in people with Lower Urinary Tract Symptoms, run by First Affiliated Hospital, Sun Yat-Sen University 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 5 inclusion and 7 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 2017. 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 Yadong Zhang, M. D. (862087755766 ext. 8373, zhyadong@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in lower urinary tract symptoms evaluated by International Prostate Symptom Score (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2017.