NCT06044883

Radiological Evaluation of the Penis Before and After a Botox Injection

Role of Shear Wave Elastography in Assessment of Penile Cavernosal Elasticity and Response to Treatment by Botox Injection in Patients With Erectile Dysfunction.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to find out if injecting Botox into men with erectile dysfunction makes their penis less stiff and gives them better erections. This will be done using a new ultrasound method. The main questions it tries to answer are: Is Botox injection safe and effective for men suffering from erectile dysfunction who failed other treatment methods? Does this new method have any radiological criteria for penile tissues? • If Botox is injected into the penis, is there a cut-off number for this technique that shows how much better things are before and after? Before and after treatment, participants will rate how much their erections have improved, and investigators will connect their answers to the findings

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Injection of Botulinum neurotoxin (BoNT)	Botulinum neurotoxin (BoNT) is produced by Clostridium botulinum, an anaerobic ,gram-positive bacterium. Poisoning with BoNT can cause botulism, resulting in generalized paralysis, respiratory failure, and death .There are seven serotypes of BoNT: A, B, C1, D, E, F, and G. BoNT-A is the most commonly used serotype for medical purposes. Since its first use in 1977 for the treatment of strabismus in children, BoNT-A has since been used in aesthetic medicine and for the treatment of a number of disorders associated with overactive striated muscles, such as strabismus, esotropia, exotropia , focal dystonia, spasticity, and movement disorders. BoNT-A has also been used in the management of some smooth-muscle disorders, such as achalasia, oesophageal spasm , ptyalism, hyperhidrosis, and intrinsic rhinitis, blepharospasm, muscle spasms and spasticity, axillary hyperhidrosis, and neurogenic detrusor muscle overactivity of the urinary bladder.
DIAGNOSTIC_TEST	Penile duplex and shear wave elastosonography (SWE).	Penile duplex study using intracavernosal injection of prostaglandin E1 (PGE1) before and after Botox injection (in the follow-up visit in the 6th week after Botox injection). Penile cavernosal arteries diameters and colored waves will be assessed. Shear wave elastosonography will be conducted comparing the stiffness of penile tissues before and after Botox injection

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Egypt