Abstract
Background Erectile dysfunction (ED) is a common condition in middle-aged men and is frequently associated with metabolic and cardiovascular comorbidities. Pharmacological therapy is effective for symptom control, but lifestyle modification may provide additional benefits when used in combination. Objective The objective of this study is to evaluate changes in erectile function and selected metabolic and hormonal parameters following combined lifestyle modification and pharmacological therapy in middle-aged men with erectile dysfunction. Methods This prospective observational study enrolled 60 men aged 40-65 years with erectile dysfunction and at least one metabolic or cardiovascular comorbidity. All participants received daily tadalafil (5 mg), along with structured counselling on diet, physical activity, sleep hygiene, weight management, smoking cessation, and alcohol reduction for three months. Erectile function was assessed using the Sexual Health Inventory for Men (SHIM) questionnaire. Laboratory parameters, including glycated hemoglobin (HbA1c), lipid profile, serum testosterone, and body weight, were measured at baseline and at three months. Paired t-tests were used to compare pre-intervention to post-intervention values, with statistical significance set at p < 0.05. Results The mean SHIM score increased from 14 ± 4 at baseline to 22 ± 5 at three months (mean change: +8 points; 95% CI: 6.2-9.7; p < 0.05). HbA1c decreased from 7.9% ± 1.5% to 6.8% ± 0.8% (-13.9%; p < 0.05), and LDL cholesterol decreased from 200 ± 50 mg/dL to 75 ± 20 mg/dL (-62.5%; p < 0.05). Mean total testosterone levels increased from 270 ± 60 ng/dL to 500 ± 120 ng/dL (+85.2%; p < 0.05), while mean body weight decreased from 85.0 ± 12 kg to 79.0 ± 9 kg (-7.1%; p < 0.05). No serious adverse events were reported. Conclusion In this prospective observational study, combined lifestyle modification and pharmacological management were associated with improvements in erectile function, glycemic control, lipid profile, serum testosterone levels, and body weight among middle-aged men with erectile dysfunction and cardiometabolic comorbidities. Further controlled studies are needed to confirm these findings and assess long-term outcomes.