Status:
RECRUITING
Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
Lead Sponsor:
Aswan University Hospital
Collaborating Sponsors:
Aswan University
Cairo University
Conditions:
Erectile Dysfunction With Diabetes Mellitus
Eligibility:
MALE
21+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Total of (32) male patients will be included in this study and will be recruited from the Andrology, Sexology \& STDs outpatient clinics- Faculty of medicine -Cairo and Aswan Universities. All those p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06583590
Start Date
August 1 2024
End Date
December 1 2025
Last Update
December 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aswan University-Faculty of Medicine
Aswān, Aswan Governorate, Egypt, 81528