Effect of Laser Therapy on Vaginal Tissue at Biomechanical, Histological and Molecular Level in Women With Pelvic Organ Prolapse - Pilot Study
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
- 否
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
Lucie Hympanova
Principal investigator
Institute for the Care of Mother and Child, Prague, Czech Republic
