EECP for Erectile Dysfunction in Elderly Hypertensive Patients

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.