Structured Lifestyle Modification Program: 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.
Study summary
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.
Eligibility
Sex
MALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Men aged 30-65 years.
* Erectile dysfunction present for at least six months.
* International Index of Erectile Function-5 score of 21 or less.
* Metabolic syndrome diagnosed according to the International Diabetes Federation criteria.
* Sexually active participants in a stable sexual relationship.
* Willingness and ability to participate in the six-month lifestyle-modification program.
* Ability to provide written informed consent.
Exclusion Criteria:
* Erectile dysfunction primarily attributable to neurogenic, psychogenic, hormonal, or postsurgical causes.
* Severe hypogonadism requiring immediate testosterone-replacement therapy.
* Use of phosphodiesterase type 5 inhibitors, intracavernosal injections, vacuum erection devices, or other erectile-dysfunction treatment that cannot be discontinued before baseline assessment.
* Significant penile anatomical abnormality that may interfere with penile duplex Doppler assessment, including Peyronie disease.
* Previous pelvic surgery or pelvic radiotherapy likely to affect erectile function.
* Severe or unstable cardiovascular disease that precludes sexual activity or participation in exercise-based lifestyle modification.
* Uncontrolled diabetes mellitus, defined in the protocol as HbA1c greater than 10%.
* Uncontrolled hypertension despite medical therapy.
* Severe renal or hepatic impairment.
* Active malignancy or life expectancy of less than one year.
* Major psychiatric illness, cognitive impairment, or inability to comply with study procedures or follow-up.
* Inability or refusal to provide written informed consent.
Primary outcome measure(s)
Change in penile peak systolic velocity from baseline to six months — Baseline and six months after initiation of the lifestyle-modification program. 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.
Trial sites (2)
Facility
City
Region
Status
Al-Hussein University Hospital, Al-Azhar University, Urology Department
Cairo
Egypt
Recruiting
Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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