Clinical trial NCT04932902: ManAgement of pRiapiSm and Its Impact on Outcomes
Official title: ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Priapism
Lead sponsor: Policlinic Hospital "G. Rodolico"
Sponsor class: OTHER
Collaborators: name: European Association of Urology Research Foundation
First posted: 2021-06-21
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with priapism: ischemic, non-ischemic or stuttered.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with Priapism

Exclusion Criteria:

* None

Primary outcomes:
measure: IIEF-5 at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: IIEF-5 at 6 months
timeFrame: 6 months
measure: Requirement for surgical management of priapism
timeFrame: Within 1 month
measure: Adverse events including erectile dysfunction, penile curvature/Peyronie's disease
timeFrame: 6 months
measure: Resolution
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Giorgio Ivan Russo
state: CT
city: Florence
country: Italy
facility: University of Florence
city: Torino
country: Italy
facility: University of Torino
city: Varese
country: Italy
facility: University of Varese
city: Porto
country: Portugal
facility: Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal
Study officials:
affiliation: Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico
name: Giorgio Ivan Russo, MD
role: PRINCIPAL_INVESTIGATOR
References: