An interventional study of Enhanced External Counterpulsation and Sham Enhanced External Counterpulsation in Hypertension and Erectile Dysfunction, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 2 sites in China. Open to male participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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Clinically significant
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Corticosteroids (steroids)
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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
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
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.
Also known as: EECP, P-ECP/TI
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.
Also known as: Sham EECP
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.
Time frame: Baseline and Day 35 (end of the 5-week treatment period)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From informed consent through Month 6 after the end of treatment
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 7 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University →