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临床试验/NCT03057067
NCT03057067终止不适用

Embolization of Pelvic Varicosities in Patients With Pelvic Congestion Syndrome

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
1
主要终点
chronic pelvic pain

研究概览

简要总结

Results of recent systematic reviews suggest favorable results of embolization for the treatment of Pelvic Congestion Syndrome (PCS) compared with pre-procedure symptoms for several outcomes, including pain reduction, overall patient satisfaction, and technical feasibility. Reported complication rates appears relatively low.

Pelvic vein embolization is a relatively new technology and the results may provide background for an evidence based decision to offer embolization of pelvic varicosities for women with PCS in Norway.

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
Female
接受健康志愿者

入选标准

  • Pelvic pain (lasting for more than 6 months)
  • Symptoms of PCS - deterioration of pain when standing and improvement in supine position (with or without dyspareunia or dysmenorrhea).
  • Confirmed pelvic varicosities by magnetic resonance examination.
  • Signed, written and informed consent

排除标准

  • Inability to communicate in Norwegian
  • Known endometriosis
  • Uterine myoma, uterine anomalies, or cancer
  • Postmenopausal
  • not having been pregnant

研究组 & 干预措施

pelvic vein embolization

Experimental

female patients referred for assessment of chronic pelvic pain at the gynecological outpatient clinic or the Multidisciplinary Pain Clinic at St. Olavs Hospital, Trondheim, Norway

干预措施: Embolization of pelvic vein varicosities (Procedure)

结局指标

主要结局

chronic pelvic pain

时间窗: 1 year

assessed by a numeric rating scale (0-10) within the questionnaire of the Norwegian Society for Pain

次要结局

  • Health related quality of life (HRQOL)(1 year)
  • Sexual function(1 year)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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