Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction Not Responding to Approved Oral or Intracorporeal Vasoactive Treatments.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Egypt
Aswan University-Faculty of Medicine
RECRUITING
Aswān
Contact Information
Primary
Hossam-Eldin Hosny Ahmed Awad, Professor
sombok@yahoo.com
01001666093
Backup
Moustafa Adam Ali, Professor
moustafa.eltaib@aswu.edu.eg
01092991101
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 32
Treatments
Other: Group 1
32 patients will be injected single intracavernosal injection of 100 unit of Botulinum toxin A accompained by oral daily tadalafil 5 mg for 3 months.
Related Therapeutic Areas
Sponsors
Collaborators: Aswan University, Cairo University
Leads: Aswan University Hospital