Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04932902 |
| Other study ID # |
122/2021 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Policlinic Hospital "G. Rodolico" |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Priapism is a urological emergency that is defined as a prolonged penile erection lasting
more than 4 h, remaining despite orgasm and in the absence of sexual stimulation. There are
three sub-types of priapism: Ischaemic, non- ischaemic and stuttering. The most common (95%
cases) of these is ischaemic priapism (IP), which represents a compartment syndrome of the
corpus cavernosa with minimal or no arterial flow into the penis. It causes time-dependent
smooth muscle damage that can result in significant morbidity (including, permanent erectile
dysfunction (ED), penile shortening, penile curvature and loss of girth) with- out prompt
intervention.
Unlike ischemic priapism, non-ischemic priapism is not a urologic emergency, both the
American Urological Association (AUA) and the European Association of Urology (EAU) recommend
conservative, non-operative, management for the treatment of NIP. Spontaneous resolution has
been documented to occur in 62% of patients [1].
Despite the very high burden of priapism and its time-dependent adverse effect on erectile
function, few studies have comprehensively defined the clinical epidemiology of this
complication nor have any compared sexual dysfunction in men with SCD with that in those
without it. Evidence-based treatment strategies for priapism are currently lacking,
especially in terms of sexual function.
However, despite the various publications in the literature, even today the published studies
show considerable bias, in terms of sample size, evaluation of reproducible outcomes, use of
internationally validated questionnaires, well-defined follow-up evaluation, as well as the
evaluation of outcome after medical or surgical treatment. For this reason, the purpose of
this international register is precisely to shed light on what may be the responses to
medical surgical treatment in patients with priapism, but in particular to set up a rational
data collection that has solid scientific bases.
Description:
Aims and objectives
Based on the previous premises, the aim of our study is to evaluate the impact of the
management of priapism from a sexual and clinical long-term outcomes point of view.
Sexual outcomes will be assessed by measured questionnaire (e.g. IIEF-15) at 3-6 months after
priapism.
Clinical outcomes will be registered as rates of resolution of acute priapism within 30'
after the onset of treatment (defined as no need for further non-surgical/surgical
interventions to resolve priapism episode), corporal injury (fibrosis or necrosis), adverse
events including erectile dysfunction, penile curvature/Peyronie's disease, requirement for
surgical management of priapism.
Sample size calculation
Since the study is designed as a prospective data collection through a registry, and since
there are no comparative analyses between different groups, it is not possible to identify a
priori sample size. However, considering that the largest case history on the field of
priapism amounts to a total of 112 patients [3], we believe that collecting data from a total
of 200 patients is sufficient in order to obtain scientifically reliable results with a high
scientific profile.
