A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors (BTXDE)

Inclusion Criteria:

• Patients diagnosed with erectile dysfunction (ED) with an inadequate response to phosphodiesterase type 5 inhibitors (PDE5 inhibitors) or to intracavernosal injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤12).
• Patients aged 30 years or older.
• Patients who have provided informed consent to participate in the study.
• Patients who, in the investigator's opinion, are able to comply with all clinical trial requirements.
• Patients who agree to attend follow-up visits and undergo the required assessments.

Exclusion Criteria:

• Severe infections or diseases, or hepatic, renal, or bone marrow insufficiency, that, in the investigator's opinion, contraindicate participation in the study.
• Known hypersensitivity to onabotulinumtoxinA (BoNT-A).
• Patients who do not consent to participate in the study.
• Patients younger than 30 years.
• Patients who underwent robotic radical prostatectomy less than 6 months prior to study enrollment.
• Patients with a known history of neurogenic injury.
• Patients with a history of radiation therapy.
• Patients with a known psychiatric disorder.
• Patients with anatomical abnormalities of the penis.
• Patients who do not agree to, or are unable to commit to, attending the scheduled follow-up visits.