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临床试验/NCT04932902
NCT04932902Enrolling By Invitation不适用

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

Policlinic Hospital "G. Rodolico"5 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
5
主要终点
IIEF-5 at 3 months

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with Priapism

排除标准

  • 未提供

结局指标

主要结局

IIEF-5 at 3 months

时间窗: 3 months

Sexual function as reported by patient or measured by questionnaire

次要结局

  • 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)

研究者

发起方
Policlinic Hospital "G. Rodolico"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgio Ivan Russo

Prof. Giorgio Ivan Russo

Policlinic Hospital "G. Rodolico"

研究点 (5)

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