Lifestyle Modification for Erectile Dysfunction in Men With Metabolic Syndrome

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.

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.