Evaluating Botox injections for erectile dysfunction
Role of Shear Wave Elastography in Assessment of Penile Cavernosal Elasticity and Response to Treatment by Botox Injection in Patients With Erectile Dysfunction.
This study is testing if Botox injections can help men with erectile dysfunction who haven't had success with pills feel better and have stronger erections.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06044883 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of Botox injections in men with erectile dysfunction who have not responded to oral medications. Using a novel ultrasound technique, the study will evaluate changes in penile stiffness and erection quality before and after treatment. Participants will provide self-assessments of their erectile function, which will be correlated with radiological findings to determine the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates are men with erectile dysfunction who have not responded to oral PDE5 inhibitors.
Not a fit: Patients with penile prostheses, Peyronie's disease, or other significant medical conditions affecting erectile function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment option for men with erectile dysfunction who have not benefited from traditional therapies.
How similar studies have performed: While the use of Botox for erectile dysfunction is an emerging area, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Faculty of Medicine, Cairo University — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.