Metabolic syndrome is associated with erectile dysfunction through obesity, insulin resistance, abnormal blood lipids, high blood pressure, and impaired blood-vessel function. This study will evaluate whether a structured six-month lifestyle-modification program can improve penile blood flow and erectile function in men with metabolic syndrome-associated erectile dysfunction. Eligible participants will receive dietary counseling, exercise guidance, weight-management advice, smoking-cessation counseling when applicable, sleep and sedentary-behavior advice, and repeated behavioral reinforcement. Erectile function, penile blood-flow measurements obtained by penile duplex Doppler ultrasonography, body measurements, and selected metabolic laboratory parameters will be assessed before the program and after six months.
This prospective single-arm interventional study will evaluate the effect of a structured six-month lifestyle-modification program on penile hemodynamic parameters and erectile function in adult men with metabolic syndrome-associated erectile dysfunction. Participants will undergo baseline assessment including demographic and clinical data collection, anthropometric measurements, blood-pressure assessment, erectile-function evaluation using the International Index of Erectile Function-5, selected laboratory investigations, and penile duplex Doppler ultrasonography after intracavernosal administration of a vasoactive agent according to the local institutional protocol. The lifestyle program will include individualized dietary counseling, recommendations for regular moderate-intensity aerobic physical activity, weight-reduction advice, smoking-cessation counseling for smokers, sleep-hygiene counseling, reduction of sedentary behavior, and behavioral reinforcement during follow-up visits. Participants will be followed monthly for adherence reinforcement and will undergo repeat clinical, laboratory, erectile-function, and penile hemodynamic assessments at six months. The principal hypothesis is that structured lifestyle modification will improve penile hemodynamic parameters, particularly peak systolic velocity, and will improve erectile-function scores in men with metabolic syndrome-associated erectile dysfunction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Participants will receive an initial standardized counseling session followed by written lifestyle instructions and repeated monthly reinforcement. The program will target improved diet quality, reduced caloric intake, increased moderate-intensity aerobic activity, weight reduction according to baseline body mass index and waist circumference, smoking cessation when applicable, improved sleep hygiene, and reduced sedentary behavior. Adherence will be assessed using participant self-report and follow-up review over six months.
Al-Hussein University Hospital, Al-Azhar University, Urology Department
Cairo, Egypt
RECRUITINGDepartment of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
Cairo, Egypt
RECRUITINGChange in penile peak systolic velocity from baseline to six months
Change in peak systolic velocity measured in centimeters per second by penile duplex Doppler ultrasonography after intracavernosal vasoactive-agent administration, comparing the baseline value with the six-month post-intervention value.
Time frame: Baseline and six months after initiation of the lifestyle-modification program.
Change in International Index of Erectile Function-5 / Sexual Health Inventory
Change in total score from baseline to 6 months. Score range 5-25; higher scores indicate better erectile function.
Time frame: Baseline and six months
Change in end-diastolic velocity
Change in the total score of the International Index of Erectile Function-5 (IIEF-5) questionnaire from baseline to 6 months. The IIEF-5 total score ranges from 5 to 25, with higher scores indicating better erectile function and lower scores indicating greater erectile dysfunction.
Time frame: Baseline and six months.
Change in resistive index
Change in penile resistive index calculated from penile duplex Doppler measurements.
Time frame: Baseline and six months.
Change in body weight
Change in body weight measured in kilograms.
Time frame: Baseline and six months.
Change in waist circumference
Change in waist circumference measured in centimeters using a standardized measurement method.
Time frame: Baseline and six months.
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