Radiological Evaluation of the Penis Before and After a Botox Injection

Last updated: September 19, 2023
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Impotence

Male Hormonal Deficiencies/abnormalities

Infertility

Treatment

Injection of Botulinum neurotoxin (BoNT)

Penile duplex and shear wave elastosonography (SWE).

Clinical Study ID

NCT06044883
MS-191-2023
  • Ages 18-70
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men with ED not responding to oral PDE5Is.

Exclusion

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 uncontrolleddiabetes mellitus, significant cardiovascular disease interfering with sexualactivity, 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

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Injection of Botulinum neurotoxin (BoNT)
Phase: 1/2
Study Start date:
June 01, 2023
Estimated Completion Date:
January 01, 2024

Connect with a study center

  • Faculty of Medicine, Cairo University

    Cairo,
    Egypt

    Active - Recruiting

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