ManAgement of pRiapiSm and Its Impact on Outcomes (MARS)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Priapism

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy
    • University of Florence
  • Torino, Italy
    • University of Torino
  • Varese, Italy
    • University of Varese
  • CT
    • Catania, CT, Italy, 95123
      • Giorgio Ivan Russo
• Portugal
  • Porto, Portugal
    • Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with priapism: ischemic, non-ischemic or stuttered.

Description

Inclusion Criteria:

• Patients with Priapism

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-5 at 3 months	Sexual function as reported by patient or measured by questionnaire	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-5 at 6 months	Sexual function as reported by patient or measured by questionnaire	6 months
Requirement for surgical management of priapism	Requirement for surgical management of priapism	Within 1 month
Adverse events including erectile dysfunction, penile curvature/Peyronie's disease	Adverse events	6 months
Resolution	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)	30 minutes

Collaborators and Investigators

• Sponsor: Policlinic Hospital "G. Rodolico"
• Collaborators: European Association of Urology Research Foundation
• Investigators: Principal Investigator: Giorgio Ivan Russo, MD, Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Penile Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Priapism
• Other Study ID Numbers: 122/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No