Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction

Launched by ASWAN UNIVERSITY HOSPITAL · Aug 31, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for men with erectile dysfunction (ED) related to diabetes. Specifically, it is looking at the combination of an injection of Botulinum toxin A and a medication called tadalafil, which is taken by mouth. The goal is to see if this combination is safe, effective, and provides long-lasting improvement for men who have not had success with other ED treatments.

To participate in the study, men must be married, have controlled diabetes, and have experienced severe erectile dysfunction that hasn't improved with other medications for at least three months. The trial is currently recruiting men aged 70 and older. If eligible, participants can expect to receive the treatment and be monitored for its effects on their erectile function. It's important to note that men with certain health issues, like heart disease or specific psychiatric conditions, may not be able to join the trial.

Gender

MALE

Eligibility criteria

• 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.