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临床试验/NCT05311748
NCT05311748已完成不适用

Prospective Cross-sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-occlusive Erectile Dysfunction

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2014年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
202
试验地点
2
主要终点
Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).

研究概览

简要总结

Background: The aim of this study is to evaluate the usefulness of Power Doppler in order to improve the diagnostic work up of veno-occlusive erectile dysfunction patients.

Materials and Methods: Two hundred and two patients affected by erectile dysfunction, mean IIEF 5 = 13.5 (12-17) for at least 6 months, were enrolled in a prospective cross-sectional study. All patients underwent Dynamic Power Doppler after intracevernous injection of vasoactive drugs. Poor responders patients subsequently underwent to cavernosometry to get a full assessment of the vascular framework.

详细描述

Veno-occlusive continence is linked both to the integrity of neurological, vascular, and endocrine structures and to the fibro-elastic characteristics of the cavernous tissue. In most subjects with Erectile Dysfunction (ED), the erectile tissue presents histological alterations such as the reduction of smooth muscle cells and the increased deposition of connective tissue. A hypothesis describes these changes as promotors for the onset of veno-occlusive dysfunction (VOD).

Dynamic cavernosometry, supplemented by contrast cavernosography, still represents the gold standard for the diagnosis of VOD allowing the visualization of the competent venous districts. These investigations, which had moderate popularity in the 1980s and underwent several variations in the methodology of execution, are rarely used today due to their invasiveness, the need for dedicated instruments and the scarce success of commonly adopted surgical treatments (vein ligation surgery).

The recent introduction of endovascular techniques sheds new light on the correct classification of vascular ED, especially in those patients with a sub-optimal response to the use of drug therapy as an alternative to prosthetic surgery.

Advances in imaging techniques, including Power Doppler (PD) ultrasonography, allow an accurate and complete study of penile circulation including the study of low-flow vessels.

The introduction of PD, during the penile duplex ultrasound routinely performed, had additionally permitted the extension of the field of the study into the arteriolar circulation of the corpora cavernosa, making possible the assessment of the vessels with a "low speed flow", like the helicine arteries, which escape the standard Doppler Pulsated evaluation; especially during the phases of the penile tumescence and partial rigidity, phases 1-2, according to Erection Hardness Score .

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Erectile dysfunction

排除标准

  • 未提供

结局指标

主要结局

Echocolour doppler Evaluation of the Index of Maintenance of Erection (n.v. <0.25).

时间窗: 90 days

Every subject will be studied by penile ultrasound with color doppler

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Luigi Pastore

PROF, MD, PhD

University of Roma La Sapienza

研究点 (2)

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