Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04932902
Other study ID # 122/2021
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Policlinic Hospital "G. Rodolico"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with Priapism Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Giorgio Ivan Russo Catania CT
Italy University of Florence Florence
Italy University of Torino Torino
Italy University of Varese Varese
Portugal Serviço de Urologia, Centro Hospitalar Universitário São João, Porto, Portugal Porto

Sponsors (2)

Lead Sponsor Collaborator
Policlinic Hospital "G. Rodolico" European Association of Urology Research Foundation

Countries where clinical trial is conducted

Italy,  Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary IIEF-5 at 3 months Sexual function as reported by patient or measured by questionnaire 3 months
Secondary IIEF-5 at 6 months Sexual function as reported by patient or measured by questionnaire 6 months
Secondary Requirement for surgical management of priapism Requirement for surgical management of priapism Within 1 month
Secondary Adverse events including erectile dysfunction, penile curvature/Peyronie's disease Adverse events 6 months
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03938454 - A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism Phase 2
Withdrawn NCT00538564 - Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia Phase 2
Withdrawn NCT01940718 - Androgen Regulation of Priapism in Sickle Cell Disease N/A
Terminated NCT00940901 - Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia Phase 2
Completed NCT00300235 - Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence