Radiological Evaluation of the Penis Before and After a Botox Injection

NCT ID: NCT06044883

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-01-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Men suffering from erectile dysfunction not responsive to phosphodiesterase-5 inhibitors (PDEI5Is)

Our study involves male participants aged 18-70 years old suffering from erectile dysfunction and not responding to oral PDE5Is All patients are sexually active. They had no history of pelvic or spinal surgeries or trauma. Patients will be recruited from the Andrology department and outpatient clinics - Kasr Alainy- Cairo University hospitals.

The study will be conducted in the ultrasound unit in the Radiology department- Kasr Alainy- Cairo University hospitals.

Group Type: EXPERIMENTAL

Injection of Botulinum neurotoxin (BoNT)

Intervention Type: PROCEDURE

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.

Penile duplex and shear wave elastosonography (SWE).

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Men with ED not responding to oral PDE5Is.

Exclusion Criteria

• Patients with penile prostheses.
• Patients diagnosed with Peyronie's disease.
• Non-vascular erectile dysfunction.
• Medical comorbidities that would limit the benefit of ICI such as uncontrolled diabetes mellitus, significant cardiovascular disease interfering with sexual activity, unstable psychiatric conditions, and the presence of anatomical, hormonal, or neurological abnormalities that would significantly impair erectile function.
• Patients with a history of radical pelvic surgery.
• Pelvic or spinal trauma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Wael Ragab

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mohamed Ragab

Role: primary

dr.wa2el@gmail.com

+201279909997

Other Identifiers

MS-191-2023

Identifier Type: -

Identifier Source: org_study_id