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临床试验/EUCTR2008-006526-34-DK
EUCTR2008-006526-34-DK进行中(未招募)1 期

Intravesikal instillation af Botulinum toxin type A til patienter med urge urininkontinens

Gynækologisk-obstetrisk afd. G, Glostrup Hospital0 个研究点目标入组 20 人开始时间: 2008年11月26日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • - Myndig habil kvinde = 18 år der forstår dansk
  • - Mindst 6 måneders anamnese med UUI som dominerende symptom i.h.t. ICS-definition
  • - Forsøgt mindst 2 forskellige antimuskarinika
  • - Heldøgns vandladningsfrekvens (TV) = 10/døgn ved 4-dages væske-vandladningsskema (VVS)
  • - Inkontinensepisodefrekvens (IEF) = 1/døgn ved 4-dages VVS
  • - Døgndiurese < 40 ml/kg
  • - Residualurin < 100 ml
  • - POP-Q = stadium 2
  • - Spontan uroflowmetri > 15 ml/sek ved ladt volumen > 150 ml, eller normal invasiv tryk-flow under-søgelse
  • - Cystometrisk overaktiv detrusor inkontinens ved volumen < 300 ml
  • - Naturlig eller kirurgisk menopause, kirurgisk sterilitet eller sikker antikonception (p-piller, spiral, de-potinjektion af gestagen, subdermal implantation, hormonal vaginalring samt transdermal depot-plaster)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Blæreneoplasier
  • - Symptomer eller tegn på neurologisk eller neuromuskulære lidelser, herunder myastenia gravis
  • - Behandling med aminoglykosider
  • - Graviditet eller amning
  • - Ønsker eller evner ikke oplæring i ren intermitterende selvkateterisation (RIK)

研究者

发起方
Gynækologisk-obstetrisk afd. G, Glostrup Hospital

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