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ManAgement of pRiapiSm and Its Impact on Outcomes

ManAgement of pRiapiSm and Its Impact on Outcomes: an International Register

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04932902
Acronym
MARS
Enrollment
200
Registered
2021-06-21
Start date
2021-06-01
Completion date
2027-12-31
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Priapism

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.

Interventions

None listed

Sponsors

European Association of Urology Research Foundation
CollaboratorOTHER
Policlinic Hospital G. Rodolico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with Priapism

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
IIEF-5 at 3 months3 monthsSexual function as reported by patient or measured by questionnaire

Secondary

MeasureTime frameDescription
IIEF-5 at 6 months6 monthsSexual function as reported by patient or measured by questionnaire
Requirement for surgical management of priapismWithin 1 monthRequirement for surgical management of priapism
Adverse events including erectile dysfunction, penile curvature/Peyronie's disease6 monthsAdverse events
Resolution30 minutesResolution of acute priapism within 30' after the onset of treatment (defined as no need for further non-surgical/surgical interventions to resolve priapism episode)

Countries

Italy, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026