Erectile Dysfunction
Conditions
Brief summary
This study aims to evaluate the clinical efficacy of intracavernosal treatment with onabotulinumtoxinA (Botox) in 114 men aged 30 years or older with erectile dysfunction who have not responded to first-line oral pharmacological treatment. For this purpose, the effects of onabotulinumtoxinA are compared with those of a placebo consisting of an intracavernosal injection of physiological saline. The study is patient-blinded. Participants in the experimental group receive 100 U of onabotulinumtoxinA diluted in 1 mL of physiological saline, while participants in the control group receive 1 mL of physiological saline.
Interventions
OnabotulinumtoxinA 100 U diluted in 1 mL of physiological saline, administered by intracavernosal injection
DRUGSaline (0.9% NaCl)
1 mL of physiological saline, administered by intracavernosal injection
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BOTOX efficacy | 6 months | Check if intracavernosal injections of onabotulinum toxin A improve erectile dysfunction in refractory patients to oral medication using questionnaires. |
Countries
Spain
Outcome results
None listed