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A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
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.
Key Details
Gender
MALE
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2024-11-25
Completion Date
2026-07-02
Last Updated
2026-09-22
Healthy Volunteers
Yes
Conditions
Interventions
OnabotulinumtoxinA (Botox ®) Injections
OnabotulinumtoxinA 100 U diluted in 1 mL of physiological saline, administered by intracavernosal injection
Saline (0.9% NaCl)
1 mL of physiological saline, administered by intracavernosal injection
Locations (1)
Clinica Universidad de Navarra
Pamplona, Navarre, Spain