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临床试验/EUCTR2017-001296-23-NL
EUCTR2017-001296-23-NL进行中(未招募)1 期

The efficacy of botulinum toxin A injection in pelvic floor muscles in chronic pelvic pain patients: a double-blinded randomised controlled trial

Radboudumc0 个研究点目标入组 92 人开始时间: 2017年7月7日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Radboudumc
入组人数
92

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

入选标准

  • -Female, >18 years
  • -Chronic pelvic pain according to the ICS with or without dyspareunia
  • -Vaginal examination with one finger possible
  • -Pelvic floor hypertonicity measured by physical examination by registered pelvic floor physiotherapist
  • -Previous physical therapy with registered physical therapist was unsuccessful
  • -Good understanding of Dutch language
  • -Willing to provide informed consent
  • 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 92
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -(wish for) Pregnancy/lactation
  • -Previous pelvic floor BTA treatment
  • -Known hypersensitivity to BTA
  • -History of neuromuscular or bleeding disorders

研究者

发起方
Radboudumc

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