ManAgement of pRiapiSm and Its Impact on Outcomes

NCT04932902 | Enrolling By Invitation

• 1 other identifier: 122/2021
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 5

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.

Conditions

Priapism

Outcome Measures

Primary Outcomes (1)

• IIEF-5 at 3 months

  Sexual function as reported by patient or measured by questionnaire

  3 months

Secondary Outcomes (4)

• IIEF-5 at 6 months

  6 months

• Requirement for surgical management of priapism

  Within 1 month

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

  6 months

• Resolution

  30 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with Priapism

You may not qualify if:

• None

Sponsors & Collaborators

• Policlinic Hospital "G. Rodolico": lead
• European Association of Urology Research Foundation: collaborator

Study Sites (5)

Giorgio Ivan Russo

Catania, CT, 95123, Italy

Location

University of Florence

Florence, Italy

Location

University of Torino

Torino, Italy

Location

University of Varese

Varese, Italy

Location

Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal

Porto, Portugal

Location

MeSH Terms

Conditions

Priapism

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Giorgio Ivan Russo, MD

  Associate Professor, Urology Unit, Policlinic Hospital G. Rodolico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giorgio Ivan Russo

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 21, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

IT (4); PT (1)