Erectile dysfunction due to organic cause
Conditions
Interventions
This is a prospective, randomized, controlled, two-arm, double-blind clinical trial. A total of 60 participants who meet the eligibility criteria will be randomly assigned to one of the intervention g
E02.319.267.530
Sponsors
Hospital Universitário Pedro Ernesto
Hospital Universitário Pedro Ernesto
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Having an International Index of Erectile Function – 5 items (IIEF-5) score of 21 points or less; being over 18 years of age; currently using at least one available treatment option for erectile dysfunction, which must be continued throughout the study; having normal libido; and having a partner able to engage in sexual intercourse for treatment assessment.
Exclusion criteria
Exclusion criteria: Presence of urogenital neoplasms; history of radical prostatectomy; testosterone levels below 350 ng/ml; diagnosed depression with the use of antidepressants; anatomical abnormalities of the genital tract; insufficient sexual activity to allow assessment of the response to the proposed treatment; and any clinical condition that contraindicates the treatment planned in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the score of the International Index of Erectile Function – 5 items (IIEF-5), comparing the values obtained before the intervention, at three months, and at six months after the application, with the aim of evaluating the efficacy of intracavernosal botulinum toxin compared to placebo in the treatment of erectile dysfunction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring the occurrence of local and systemic adverse events related to the intervention, recorded throughout the entire follow-up period, to assess the safety of intracavernosal botulinum toxin administration compared to placebo. | — |
Countries
Brazil
Contacts
Public ContactGabriel Crelier
Hospital Universitário Pedro Ernesto
Outcome results
None listed