Erectile Dysfunctions
Conditions
Keywords
Erectile Dysfunction, ED, Sildenafil, Tadalafil, PDE5i Non-Responders, Combination Therapy
Brief summary
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
Interventions
DRUGTadalafil 5 mg & Sildenafil 100mg
daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg
DRUGSildenafil 100mg & placebo
Daily Placebo combined with on demand Sildenafil 100mg
Sponsors
Mansoura University
Cairo University
Ain Shams University
Aswan University
Luxor university
Assiut University
Minia University
Alexandria University
Tanta University
October 6 University
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sexually active male. * History of ED for ≥6 months. * Erectile function domain of IIEF-15 score \<17. * Documented failure to respond to PDE-5I \[definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4 occasions in spite of accurate timing and good sexual stimulation\]. * Stable sexual relationship ≥ 6 months.
Exclusion criteria
* Penile anatomical deformities or Peyronie's disease. * Pelvic surgery or radiation. * Active malignancy or severe systemic illness. * Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting. * Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension). * Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Index of Erectile Function-5 (IIEF-5) total score | from baseline to 12 weeks after starting treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale | from baseline to 12 weeks after starting treatment | The Erection Hardness Score (EHS) is a validated 4-point scale assessing penile rigidity, with higher scores indicating better erectile hardness. |
| Change in International Index of Erectile Function (IIEF-15) total score | from baseline to 12 weeks after treatment | 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. |
| Incidence and severity of adverse events graded according to CTCAE version 5.0 | from baseline up to 12 weeks after treatment | 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. |
Countries
Egypt
Contacts
CONTACTAhmed A Shokeir+2, professor of Urology
STUDY_CHAIRAhmed A Shokeir, professor of urology
Urology & Nephrology Center, Masnoura university, Egypt
Outcome results
None listed