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Inflatable leg cuffs tested as a Two-for-One therapy for high blood pressure and erectile dysfunction

NCT ID NCT07831551

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether enhanced external counterpulsation (EECP), a noninvasive treatment that uses inflatable cuffs on the legs and buttocks timed to the heartbeat, can improve blood pressure and erectile function in men aged 60 to 75 who have both hypertension and erectile dysfunction. The trial enrolls 106 men at two centers and randomly assigns them to active EECP or a sham version, alongside their usual blood pressure medication. Active treatment involves 35 one-hour sessions over five weeks. The main measure is change in average office blood pressure, with additional checks on erectile function, vascular health, quality of life, sleep, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enhanced external counterpulsation (EECP), a noninvasive device treatment using inflatable leg and buttock cuffs timed to the heartbeat
What this could lead to
If it works, EECP could offer a non-drug way to help lower blood pressure and improve erectile function in older men who have both conditions.
What could go wrong
This is a small, single-region trial with 106 men, and sham-controlled device studies can be hard to blind. EECP requires 35 daily sessions, and results may not apply to other groups or last beyond the 6-month follow-up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Uncontrolled hypertension (\>180/110 mmHg) or secondary hypertension. * Diabetes mellitus. * Current use of other medications that may significantly affect blood pressure, such as glucocorticoids. * 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. * Participation in another clinical trial within the previous 3 months. * A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis. * A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000, China

  • The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University

    Shenzhen, Guangdong, 518107, China

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