跳至主要内容
临床试验/NCT05898191
NCT05898191进行中(未招募)不适用

Effect of Laser Therapy on Vaginal Tissue at Biomechanical, Histological and Molecular Level in Women With Pelvic Organ Prolapse - Pilot Study

Institute for the Care of Mother and Child, Prague, Czech Republic2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
15
试验地点
2
主要终点
uniaxial biomechanical analysis

研究概览

简要总结

Pelvic floor disorders, including prolapse, incontinence, and vulvovaginal atrophy decrease the quality of life of every fourth woman. Recent therapy including habits change, rehabilitation, surgery, or hormonal replacement is not possible in all patients. Laser therapy is currently being proposed as an alternative. Laser therapy was brought to the gynecological field from dermatology, where it is used for facial rejuvenation (wrinkles) and treatment of other skin abnormalities. In dermatology, the laser has proven its efficacy at the molecular and histological levels. However, this concept was brought to gynecology without comparable confirmation. The skin and vagina have a different structures, therefore effects of laser may differ. Patient satisfaction with the clinical effects of laser has been reported. However, based on recent reviews and sheep studies knowledge about histological and other effects is limited. The goal of this study is to gain knowledge about the histological, biomechanical effects and molecular effects of laser on vagina. Control samples were collected from women undergoing colporrhaphy. The laser group underwent laser treatment prior to the surgery. The gained knowledge may improve laser protocols and in the future maybe laser therapy will become standard treatment in urogynecology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • pelvic organ prolapse stage II (cystocele Ba ≥ -1)
  • planned surgical treatment (anterior colporrhaphy)
  • menopausal

排除标准

  • surgical treatment at a location of interest
  • use of systemic or vaginal estrogens within last 12 months

结局指标

主要结局

uniaxial biomechanical analysis

时间窗: within month after completion of specimens

Young's modulus of elasticity at low and high deformations

次要结局

  • quantitative immunohistochemistry- picrosirius red(within 6 months after completion of specimens)
  • quantitative histological analysis - epithelial thickness(within 6 months after completion of specimens)
  • quantitative immunohistochemistry -von Willebrand factor (vWF)(within 6 months after completion of specimens)
  • quantitative immunohistochemistry -orcein(within 6 months after completion of specimens)
  • molecular analysis - markers of inflammation(within 6 months after results of histological analysis)
  • molecular analysis - connective tissue remodeling(within 6 months after results of histological analysis)

研究者

发起方
Institute for the Care of Mother and Child, Prague, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucie Hympanova

Principal investigator

Institute for the Care of Mother and Child, Prague, Czech Republic

研究点 (2)

Loading locations...

相似试验