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临床试验/NCT04370652
NCT04370652已完成不适用

Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Peyronie's Disease Questionnaire (PDQ)

研究概览

简要总结

Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Peyronie's Disease Questionnaire (PDQ)

时间窗: every 4 weeks for 2 years

Peyronie's Disease Questionnaire (PDQ) : Change in baseline Peyronie's Disease Questionnaire Score each 4 weeks, i.e. before each new injection ; for up 2 years

次要结局

  • Penile curvature angulation(every 4 weeks for 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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