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NCT07831551

EECP for Erectile Dysfunction in Elderly Hypertensive Patients

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

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. 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.

Official title: Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial

Key Details

Gender

MALE

Age Range

60 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2026-10-01

Completion Date

2027-10-01

Last Updated

2026-09-21

Healthy Volunteers

Conditions

Hypertension Erectile Dysfunction

Interventions

DEVICE

Enhanced External Counterpulsation

Active enhanced external counterpulsation (EECP) will be delivered using an electrocardiogram-triggered EECP system (model P-ECP/TI). Pneumatic cuffs placed around the calves, thighs, and buttocks will inflate sequentially during cardiac diastole and deflate before systole. The cuff pressure will be set at 250 to 275 mmHg. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.

DEVICE

Sham Enhanced External Counterpulsation

Sham enhanced external counterpulsation will be administered using the same EECP device, cuff placement, electrocardiogram triggering, procedures, session duration, frequency, and treatment period as active EECP. The cuff pressure will be set at 70 mmHg, which is intended to provide a treatment experience similar to active EECP without producing effective counterpulsation. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.

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.

Locations (2)

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

Shenzhen, Guangdong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China