Overview
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.
Description
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.
Eligibility
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.
