The goal of this clinical trial is to evaluate whether daily dosing with tadalafil 5 mg combined with on-demand sildenafil 100 mg can improve erectile function in men with erectile dysfunction (ED) who do not respond to PDE5 inhibitor alone. The main questions it aims to answer are: * Does the combination of daily tadalafil and on-demand sildenafil lead to a greater improvement in erectile function (measured by the IIEF-EF domain) compared with on-demand sildenafil alone? * Is the combination therapy safe and well tolerated in this patient population? Researchers will compare: * Group A: Daily tadalafil 5 mg plus on-demand sildenafil 100 mg * Group B: Daily placebo plus on-demand sildenafil 100 mg to determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction. Participants will: * Undergo baseline assessment including medical history, physical examination, and laboratory tests. * Be randomly assigned to one of the two treatment groups. * Take the assigned medications for 12 weeks. * Complete follow-up evaluations at 4, 8, and 12 weeks, including: International Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
500
daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg
Daily Placebo combined with on demand Sildenafil 100mg
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGFaculty of medicine, Alexandria University
Alexandria, Egypt
RECRUITINGFaculty of medicine, Aswan university
Aswān, Egypt
RECRUITINGFaculty of Medicine - Assiut University
Asyut, Egypt
RECRUITINGCairo University, faculty of medicine
Cairo, Egypt
RECRUITINGFaculty of medicine, Ain Shams University
Cairo, Egypt
RECRUITINGFaculty of medicine, Azhar University
Cairo, Egypt
RECRUITINGFaculty of medicine, october 6 Univeristy
Cairo, Egypt
RECRUITINGFaculty of medicine, Luxor university
Luxor, Egypt
RECRUITINGfaculty of medicine, Minya University
Minya, Egypt
RECRUITING...and 1 more locations
Change in International Index of Erectile Function-5 (IIEF-5) total score
The IIEF-5 is a validated 5-item questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function.
Time frame: from baseline to 12 weeks after starting treatment
Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale
The Erection Hardness Score (EHS) is a validated 4-point scale assessing penile rigidity, with higher scores indicating better erectile hardness.
Time frame: from baseline to 12 weeks after starting treatment
Change in International Index of Erectile Function (IIEF-15) total score
The International Index of Erectile Function (IIEF-15) is a validated 15-item questionnaire assessing erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction, with total scores ranging from 5 to 75; higher scores indicate better sexual function.
Time frame: from baseline to 12 weeks after treatment
Incidence and severity of adverse events graded according to CTCAE version 5.0
Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: from baseline up to 12 weeks after treatment
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