Efficacy of Daily 5-mg Tadalafil as Adjunctive Therapy Versus Monotherapy in Men With On-Demand PDE5 Inhibitor-Resistant Erectile Dysfunction: A Prospective Randomized Trial
This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.
• Age: 18 to 70 years.
• Diagnosis: Erectile dysfunction for at least 6 months.
• PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:
• International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.
• Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.
• Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.
• Stable relationship: Sexually active with a female partner for at least 6 months.
• Informed consent: Willing and able to provide written informed consent.