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Enrolling by Invitation

NCT Number: NCT04932902

ManAgement of pRiapiSm and Its Impact on Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Giorgio Ivan Russo, Catania, CT, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Priapism

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. IIEF-5 at 3 months

    Time frame: 3 months

    Sexual function as reported by patient or measured by questionnaire

Secondary outcomes

  1. IIEF-5 at 6 months

    Time frame: 6 months

    Sexual function as reported by patient or measured by questionnaire

  2. Requirement for surgical management of priapism

    Time frame: Within 1 month

    Requirement for surgical management of priapism

  3. Adverse events including erectile dysfunction, penile curvature/Peyronie's disease

    Time frame: 6 months

    Adverse events

  4. Resolution

    Time frame: 30 minutes

    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)

Sponsors and collaborators

Lead sponsor

Policlinic Hospital "G. Rodolico"

Other

Collaborators

  • European Association of Urology Research Foundation

Registry information

Official study title

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

Acronym: MARS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 21, 2021
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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