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临床试验/NCT05480683
NCT05480683进行中(未招募)不适用

Addition of Pelvic CT With Agatston Calcium Score for Patients With Peyronie Disease May Change Management Decisions in Patients With Calcified Plaque

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
12
试验地点
2
主要终点
Calcium volume of penile plaques

研究概览

简要总结

The purpose of this study is to find out how including a CT exam of the penis can help urologists make treatment decisions for patients with calcified Peyronie's disease.

详细描述

Peyronie disease (PD) affects up to 10% of men with fibrosing penile plaques causing penile pain and progressing to deformity. Calcified plaque develops in up to 20% of these patients, excluding them from medical therapy with collagenase injection and often requiring more extensive surgery for treatment. PDDU identifies plaque distribution and characteristics while the Doppler exam evaluates for any underlying erectile dysfunction. Calcification can make PDDU difficult to identify the full extent of plaque since the shadow caused by calcification may prevent accurate measurement and over or underestimate the plaque size. In addition, the ultrasound exam is operator dependent and requires injection of an agent to induce erection. Since current clinical practice excludes men with any degree of calcification presumed on physical examination or demonstrated on PDDU from receiving injection therapy they may be triaged to surgical management instead. A prior study found the presence of calcifications at ultrasound had odd ratio 1.75 of patient progressing to surgical management, while fibrosis without calcification did not have increased odds of surgical management. Noncontrast pelvis CT provides three dimensional detail of calcified plaque including parts of the penis that are difficult to image with PDDU, and calcification does not have artifact on CT. By adding non-contrast pelvis CT with Agatston calcium scoring to PDDU and clinical parameters of penile deformity, patients may be better stratified into the appropriate treatment pathway.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Peyronie Disease with stable curvature considered for therapeutic intervention
  • PDDU obtained at clinic visit
  • Able to provide informed consent

排除标准

  • Implanted penile prosthesis or implanted urethral sphincter that would prevent adequate CT images
  • Acute active Peyronie disease that would not be managed with injection or surgical therapy

结局指标

主要结局

Calcium volume of penile plaques

时间窗: Baseline

Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to measure the calcium volume (mm3)

Calcium score of penile plaques

时间窗: Baseline

Peyronie plaques with calcification can be identified with noncontrast CT. The Agatston calcium scoring software is used to mark the calcified plaques to calculate the Agaston calcium score

Treatment plans adjustment after CT

时间窗: Within 2 weeks of intervention

Number of treatment plans to be adjusted after CT results. The treatment options for Peyronie's disease are observation, penile traction therapy, oral medication, medication injection, plaque incision, plaque excision, penile plication with graft, penile plication without graft, penile implant with plaque incision and graft, or penile implant with plication. The study urologist plan will be documented before CT results. After CT results the study urologist will or will not adjust the treatment plan.

次要结局

  • Calcified plaque continuity(Baseline)
  • Calcified plaque length(Baseline)
  • Calcified plaque number(Baseline)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren F. Alexander

Principal Investigator

Mayo Clinic

研究点 (2)

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