Radiological Evaluation of the Penis Before and After a Botox Injection

Cairo University (CU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Erectile Dysfunction

Treatments: Procedure: Injection of Botulinum neurotoxin (BoNT); Diagnostic Test: Penile duplex and shear wave elastosonography (SWE).

Study type: Interventional

Funder types: Other

Identifiers

NCT06044883

MS-191-2023

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Penile duplex and shear wave elastosonography (SWE).

Procedure: Injection of Botulinum neurotoxin (BoNT)