Leg cuff treatment for erectile dysfunction in older men with high blood pressure
Tests enhanced external counterpulsation in older men with hypertension and erectile dysfunction.
Key facts
- Who runs it
- Qilu Hospital of Shandong University
- Where
- Jinan and Shenzhen, ChinaSee the 2 sites
- Trial code
- Registry title
- EECP for Erectile Dysfunction in Elderly Hypertensive Patients
- Status
- Not yet recruiting
- People taking part
- 106 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 1 Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Enhanced External Counterpulsation
- Sham Enhanced External Counterpulsation
- Record updated
- 21 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 60 to 75 with both high blood pressure and erectile dysfunction. It tests a leg-cuff treatment (EECP) against a sham treatment.
- Age
- 60 to 75 years
- Sex
- Men only, with a stable female sexual partner
- Disease stage
- High blood pressure (hypertension), including people already on blood pressure medicine, and erectile dysfunction with an IIEF-5 score of 21 or less for at least 3 months
- Earlier treatment
- No phosphodiesterase type 5 inhibitors, hormones, health supplements or other treatments for erectile function, including traditional Chinese medicines, in the 3 months before joining
Main reasons for not taking part
- Severe heart disease, such as NYHA class IV heart failure or ejection fraction under 30%
- Uncontrolled hypertension above 180/110 mmHg, or secondary hypertension
- Diabetes mellitus
- Cancer or another severe disease of the heart, liver, kidneys, blood-forming system or another major organ
- A contraindication to EECP, such as severe aortic regurgitation, aortic aneurysm, active thrombophlebitis or deep vein thrombosis in the legs
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Male participants aged 60 to 75 years with a stable sexual partner
- Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140/90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135/85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130/80 mmHg, daytime blood pressure ≥135/85 mmHg, or nighttime blood pressure ≥120/70 mmHg. Participants with a previous diagnosis of hypertension who are currently receiving antihypertensive treatment remain eligible even if their current blood pressure is below these thresholds
- Diagnosis of erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score ≤21 with a duration of at least 3 months
- Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study
- No treatment with phosphodiesterase type 5 inhibitors, hormones, health supplements, or other treatments intended to improve erectile function, including traditional Chinese medicines, within 3 months before enrollment
- Voluntary participation and ability to read, understand, and provide written informed consent
Who cannot take part
- Current use of other medications that may significantly affect blood pressure, such as glucocorticoids
- Participation in another clinical trial within the previous 3 months
- Uncontrolled hypertension (>180/110 mmHg) or secondary hypertension
- Diabetes mellitus
- A condition associated with an increased risk of priapism, such as sickle cell anemia or leukemia
- Peptic ulcer disease, a bleeding disorder, visual abnormality, or hearing impairment
- Malignant tumor or another severe primary disease involving the heart, liver, kidneys, hematopoietic system, or another major organ or system
- Neurological or psychiatric disease that prevents cooperation with study procedures, or unwillingness to cooperate
- History of alcohol or drug abuse
- A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis
- Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction <30%, malignant arrhythmia, or other clinically significant cardiac conditions
- A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 75 years old?
Where in China
- Qilu Hospital of Shandong UniversityJinan, ChinaContact: Lin Shen, MDNo longer taking part
- The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen UniversityShenzhen, ChinaContact: Xujun Xuan, MDNo longer taking part
About the trial
What the trial wants to find out
Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow.
Read full original descriptionShow less
The purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being.
A total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive.
The main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events.
Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.
The 2 groups in the trial
- Active EECPTreatment being tested
Participants will continue their usual antihypertensive treatment and receive active enhanced external counterpulsation (EECP). Active EECP will be delivered using an electrocardiogram-triggered EECP device with sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
Treatment: Enhanced External Counterpulsation
- Sham EECPSham treatment, for comparison
Participants will continue their usual antihypertensive treatment and receive sham enhanced external counterpulsation using the same device, cuff placement, procedures, and treatment schedule as the active intervention. The cuff pressure will be set at 70 mmHg, which is not expected to produce effective counterpulsation. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.
Treatment: Sham Enhanced External Counterpulsation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial
- Plain-language title
- Leg cuff treatment for erectile dysfunction in older men with high blood pressureGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07831551, who can take part
- Record updated
- 21 September 2026