Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectil… (NCT06583590) | Clinical Trial Compass
RecruitingPhase 2/3
Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
Egypt32 participantsStarted 2024-08-01
Plain-language summary
Study is aiming to evaluate safety, efficacy and durability of intracavernosal injection (ICI) of Botulinum toxin A plus oral tadalafil in controlled diabetic men with refractory Erectile Dysfunction.
Who can participate
Age range21 Years
SexMALE
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Inclusion Criteria:
* Adult controlled diabetic married men who proved to be vasculogenic ED by Penile Duplex.
* Men who had shown an insufficient response for at least 3 months to the registered PDE5-Is at the highest approved dose, either on-demand or daily, or to PGE1 ICIs.
* Severe erectile dysfunction (erection hardness score ≤ E3 after intracavernosal injection of PGE-1).
Exclusion Criteria:
* Men who had cardiovascular disease interfering with sexual activity.
* Men with history of an unstable psychiatric conditions
* Presence of penile anatomical abnormalities that would significantly impair erectile function.
* History of spinal or pelvic radical surgery.