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NCT04932902: MARS

ManAgement of pRiapiSm and Its Impact on Outcomes

ENROLLING BY INVITATION Last updated 1 August 2025
What this trial tests

trial in Priapism in 200 participants. Enrolling by invitation.

Timeline
1 June 2021
Primary endpoint
1 June 2026
31 December 2027

Quick facts

Lead sponsorPoliclinic Hospital "G. Rodolico"
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment200
Start date1 June 2021
Primary completion1 June 2026
Estimated completion31 December 2027
Sites5 locations across Portugal, Italy

Conditions studied

Sponsor

Policlinic Hospital "G. Rodolico"

Who can join

18 and older, male only, with Priapism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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