Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583590
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients are complaining of erectile dysfunction Unresponsive to Approved Pharmacological Treatments Each patient will have an informed consent obtained prior to conducting the study
All patients will be subjected to the following
History taking
Clinical examination general and local genital examination
International Index of Erectile Function IIEF-5 before and after treatment Rosen et al 2002
Erection Hardness Score EHS before and after treatment Mulhall et al 2006
Global assessment questionnaire after treatment Giuliano et al 2007
All patients will be examined by Duplex Doppler ultrasonography in the basal condition and after the induction of penile erection with the assistance of an intracavernous injection of alprostadil 20 μgmL
All patients will receive single dose of ICI of 100u of BTXA combined with 5mg oral Tadalafil once daily for 3 months
The subjects will be re-examined and International Index of Erectile Function IIEF-5 Erection Hardness Score EHSand penile color Doppler ultrasound with PGE-1 injection will be done at 6 and 12 weeks from the start of therapy in addition to Global assessment questionnaire will be done at 12 weeks from the start of therapy
Procedure
The patients will lied down in supine position After cleansing the skin with alcohol intracavernosal injection of single dose 100U BTX-A diluted in isotonic saline 2cm proximal to coronal margin at right and left sides will be performed and the injection site will be pressed directly for two minutes To prevent systemic toxicity a veno-occlusive ring will be used at the base of the penis at the time of injection and will be kept in place for 15 minutes after injection
All patients will be subjected to the following
History taking
Clinical examination general and local genital examination
International Index of Erectile Function IIEF-5 before and after treatment Rosen et al 2002
Erection Hardness Score EHS before and after treatment Mulhall et al 2006
Global assessment questionnaire after treatment Giuliano et al 2007
All patients will be examined by Duplex Doppler ultrasonography in the basal condition and after the induction of penile erection with the assistance of an intracavernous injection of alprostadil 20 μgmL
All patients will receive single dose of ICI of 100u of BTXA combined with 5mg oral Tadalafil once daily for 3 months
The subjects will be re-examined and International Index of Erectile Function IIEF-5 Erection Hardness Score EHSand penile color Doppler ultrasound with PGE-1 injection will be done at 6 and 12 weeks from the start of therapy in addition to Global assessment questionnaire will be done at 12 weeks from the start of therapy
Procedure
The patients will lied down in supine position After cleansing the skin with alcohol intracavernosal injection of single dose 100U BTX-A diluted in isotonic saline 2cm proximal to coronal margin at right and left sides will be performed and the injection site will be pressed directly for two minutes To prevent systemic toxicity a veno-occlusive ring will be used at the base of the penis at the time of injection and will be kept in place for 15 minutes after injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None