Prospective Cross-sectional Evaluation of Penile Helicine Circulation by Power Doppler During Dynamic Ultrasound in Veno-occlusive Erectile Dysfunction
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
- 否
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
Antonio Luigi Pastore
PROF, MD, PhD
University of Roma La Sapienza
