EECP for Erectile Dysfunction in Elderly Hypertensive Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Erectile Dysfunction
• Intervention / Treatment: Device: Enhanced External Counterpulsation; Device: Sham Enhanced External Counterpulsation

Detailed Description

This is a two-center, participant-masked, randomized, sham-controlled clinical trial designed to evaluate the efficacy and safety of enhanced external counterpulsation (EECP) in older men with hypertension and erectile dysfunction.

Hypertension and erectile dysfunction may share vascular endothelial dysfunction as an underlying pathophysiological mechanism. EECP is a noninvasive external counterpulsation treatment that may improve systemic blood flow, tissue perfusion, and vascular endothelial function. This study will primarily evaluate the effect of EECP on blood pressure and will also explore its effects on erectile function and vascular function.

A total of 106 male participants aged 60 to 75 years will be enrolled. Eligible participants must have hypertension and erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score of 21 or lower with a duration of at least 3 months.

Participants will be randomly assigned in a 1:1 ratio to the active EECP group or the sham EECP group. Stratified block randomization will be used, with study center as the stratification factor and a block size of 4. Participants will be masked to treatment assignment. Both groups will continue their usual antihypertensive treatment, and antihypertensive medication regimens will be kept stable whenever clinically feasible during the study.

Participants assigned to the active EECP group will receive electrocardiogram-triggered 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.

Participants assigned to the sham EECP group will undergo the same treatment procedures using the same device and treatment schedule, but the cuff pressure will be set at 70 mmHg. This pressure is intended to preserve a treatment experience similar to active EECP without producing effective counterpulsation.

The primary objective is to compare the change from baseline to the end of the treatment period in average office blood pressure between the active EECP and sham EECP groups. Average office blood pressure will be calculated from three consecutive blood pressure measurements obtained at the study visit.

Secondary and exploratory assessments will include immediate changes in blood pressure and heart rate before, during, and after individual treatment sessions; changes in office blood pressure after 20 treatment sessions and during follow-up; and parameters obtained from 24-hour ambulatory blood pressure monitoring.

Erectile function will be assessed using the IIEF-5, Sexual Encounter Profile questions 2 and 3, the Global Assessment Question, the Self-Esteem and Relationship questionnaire, and the Erectile Hardness Score.

Other assessments will include serum nitric oxide and vascular endothelial growth factor levels; vascular endothelial function; penile arterial blood-flow parameters; systemic hemodynamic parameters; pulse wave velocity; heart rate variability; psychological status; sleep quality; quality of life; and nocturia.

Safety will be evaluated by recording the occurrence, severity, and relationship to treatment of adverse events, including skin injury, arrhythmia, and priapism.

Study assessments will be conducted at baseline, after 20 EECP sessions, at completion of treatment, and at 1, 3, and 6 months after treatment. The study hypothesis is that active EECP will produce a greater improvement in blood pressure than sham EECP and may also improve erectile function, potentially through beneficial effects on vascular endothelial function.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Shen, MD; Phone Number: +8618560082257; Email: slmm321@126.com
• Study Contact Backup: Name: Shihao Sun; Phone Number: +86-13853993929; Email: sunshihao131@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518107
      • The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University
      • Contact: Xujun Xuan, MD; Phone Number: +86-18802006303; Email: xxjun777@163.com
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
      • Contact: Lin Shen, MD; Phone Number: +8618560082257; Email: slmm321@126.com
      • Contact: Shihao Sun; Phone Number: +86-13853993929; Email: sunshihao131@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active EECP; 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.	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.; Other Names: EECP; P-ECP/TI
Sham Comparator: Sham EECP; 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.	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.; Other Names: Sham EECP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment	Office systolic blood pressure will be measured three consecutive times at the study visit according to the standardized blood pressure measurement procedure. The arithmetic mean of the three measurements will be used as the mean office systolic blood pressure. The outcome will be calculated as the mean office systolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.	Baseline and Day 35 (end of the 5-week treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Office Diastolic Blood Pressure at the End of Treatment	Office diastolic blood pressure will be measured three consecutive times at the study visit. The arithmetic mean of the three measurements will be used. The outcome will be calculated as the mean office diastolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.	Baseline and Week 5 (end of the treatment period)
Mean Within-Session Change in Supine Systolic Blood Pressure	Supine systolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.	At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Diastolic Blood Pressure	Supine diastolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.	At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Mean Within-Session Change in Supine Heart Rate	Supine heart rate will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in beats per minute.	At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment
Change From Baseline in Mean Office Systolic Blood Pressure at Follow-up Assessments	Office systolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.	Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Office Diastolic Blood Pressure at Follow-up Assessments	Office diastolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.	Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Systolic Blood Pressure	Twenty-four-hour mean systolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 24-Hour Mean Diastolic Blood Pressure	Twenty-four-hour mean diastolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the 5-Item International Index of Erectile Function Total Score	Erectile function will be assessed using the 5-item International Index of Erectile Function. The total score will be calculated according to the prespecified scoring method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 2	Sexual Encounter Profile Question 2 asks whether the participant was able to insert the penis into the partner's vagina. The percentage of participants answering Yes will be calculated at each prespecified assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to Sexual Encounter Profile Question 3	Sexual Encounter Profile Question 3 asks whether the participant's erection lasted long enough for successful intercourse. The percentage of participants answering Yes will be calculated at each prespecified assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Percentage of Participants Answering Yes to the Global Assessment Question	Participants will answer whether the treatment received during the study improved their erections. The percentage of participants answering Yes will be calculated at each prespecified assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Self-Esteem and Relationship Questionnaire Score	Self-esteem and sexual relationship outcomes will be assessed using the Self-Esteem and Relationship questionnaire. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Erectile Hardness Score	Erection hardness will be assessed using the Erectile Hardness Score, ranging from Grade 1 to Grade 4, with higher grades indicating greater erection hardness. Change from baseline will be evaluated at each prespecified assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Serum Nitric Oxide Level	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Serum Vascular Endothelial Growth Factor Level	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment
Change From Baseline in Brachial Artery Flow-Mediated Dilation	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Reactive Hyperemia Index	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Resistance Index	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Penile Artery Peak Systolic Velocity	The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Cardiac Output	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Stroke Volume Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Arterial Pressure	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in SSVRI	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Left Ventricular Stroke Work Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Ejection Phase Contractility Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Inotropic State Index	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Systemic Vascular Resistance	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Total Vascular Resistance	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Mean Heart Rate	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pulse Wave Velocity	The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Hamilton Anxiety Rating Scale Total Score	Anxiety severity will be assessed using the prespecified validated version of the Hamilton Anxiety Rating Scale (HAM-A). The total score will be calculated according to the standard scoring method, with higher scores indicating greater anxiety severity. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in [Full Name of Depression Scale] Total Score	Depressive symptoms will be assessed using the prespecified validated version of the [full name and abbreviation of the depression scale]. The total score ranges from [minimum score] to [maximum score], with higher scores indicating [greater or lower] depressive symptom severity. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Pittsburgh Sleep Quality Index Global Score	Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be calculated separately at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in 36-Item Short Form Health Survey Domain Scores	Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Eight domain scores will be calculated according to the standard scoring algorithm and transformed to a scale from 0 to 100, with higher scores indicating better health status. Change from baseline will be calculated separately for each domain at each post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Standard Deviation of Normal-to-Normal Intervals	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The standard deviation of all normal-to-normal intervals (SDNN) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Root Mean Square of Successive Normal-to-Normal Interval Differences	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The root mean square of successive normal-to-normal interval differences (RMSSD) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Percentage of Successive Normal-to-Normal Intervals Differing by More Than 50 Milliseconds	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50) will be calculated and reported as a percentage. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Low-Frequency Power	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in High-Frequency Power	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. High-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Very-Low-Frequency Power	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Very-low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in Total Heart Rate Variability Power	Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Total heart rate variability power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Change From Baseline in the Number of Nocturia Episodes per Night	The number of nocturia episodes will be recorded based on the participant's report of the number of times the participant wakes from sleep to urinate during the usual nighttime sleep period. Change from baseline will be calculated separately at each prespecified post-baseline assessment.	Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment
Number of Participants With Adverse Events	All adverse events occurring after informed consent will be recorded and assessed for severity and relationship to the study intervention. Events of special interest include skin injury, arrhythmia, and priapism. The number and percentage of participants experiencing one or more adverse events will be summarized by study arm.	From informed consent through Month 6 after the end of treatment

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 6, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Ambulatory Blood Pressure Monitoring; Vascular Endothelial Function; Older Men; Enhanced External Counterpulsation; EECP
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Hypertension; Erectile Dysfunction
• Other Study ID Numbers: KYLL-2026-05-021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be shared with external researchers because the study includes sensitive personal health and sexual-function information and is subject to institutional ethics, privacy, and data-protection requirements. Study results will be reported only in aggregate form through scientific publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No