Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Viscoelasticity
研究概览
简要总结
Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years
- •Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA < 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer)
- •International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction)
- •Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization
- •Planned bilateral nerves-paring prostatectomy
排除标准
- •Moderate or severe ED based in IIEF criteria (score < 21)
- •History of prior pelvic or penile surgery
- •Current or prior androgen deprivation therapy
- •Planned non-nerve sparing prostatectomy
研究组 & 干预措施
Ultrasound viscoelastography (UVE) in radical proctectomy recovery
Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy.
干预措施: Ulrasound Vibroelastography (UVE) (Diagnostic Test)
结局指标
主要结局
Change in Viscoelasticity
时间窗: Baseline, 3 months, 6 months and 9 months post-prostatectomy
As measured by Ultrasound Vibroelastography (UVE)
次要结局
未报告次要终点
研究者
Matthew (Matt) J. Ziegelmann
Principal Investigator
Mayo Clinic