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临床试验/NCT04218942
NCT04218942已完成不适用

Interest of Rocamed Urethral Device for Treatment of Acute or Chronic Urinary Retention in Males

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年6月12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
15
试验地点
2
主要终点
Percentage of patients in whom the device will be inserted only by hand manipulation

研究概览

简要总结

Prospective non randomized study of the feasibility of the insertion of Rocamed urethral device by hand manipulation, i.e., without use of cystoscopy, sonography or fluoroscopy. Patients with an acute urinary retention treated by Foley catheterization in the Emergency department have a few days later a trial of Foley removal in the ambulatory unit of the Urology department. In case of failure of the Foley removal trial, i.e., recurrence of urinary retention, patients will be proposed either the insertion of a new Foley or insertion of the urethral device. After signature of an informed consent, insertion of the urethral device will be performed after instillation in the urethra of a local anesthetic gel. Device insertion success rate and complications will be studied. The device will be left in place for one month. Tolerance and complications during the month with the device in place will be studied. At one month the device will be removed: the ease of retrieval of the device and complications will be studied. Patient and doctor satisfaction with the urethral device will be compared to patient and doctor satisfaction with the Foley.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Male > 18 years old
  • Acute retention treated by Foley
  • Failure of Foley removal trial
  • Clear urine
  • No urinary infection
  • Efficient striated sphincter

排除标准

  • Urethral stenosis
  • Hematuria macroscopic
  • Urinary infection
  • Anticoagulant treatment
  • Lidocaine allergy

结局指标

主要结局

Percentage of patients in whom the device will be inserted only by hand manipulation

时间窗: Day 0

次要结局

  • Flowmetry with device in place ml/sec(Day 0 (Day of device insertion))
  • Patient tolerance during retrieval of the device : analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)(1 month)
  • Patient tolerance during device insertion: analogic visual scale 0-10 (0 : no pain / 10 : worst pain imaginable)(Day 0 (Day of device insertion))
  • Patient tolerance during one month: analogic visual scale 0-10 (0 : excellent tolerance / 10 : intolerable)(1 Month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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