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.