Pelvic Floor Disorders, Vaginal Atrophy
Conditions
Brief summary
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.
Interventions
non-ablative vaginal laser application
Sponsors
Department of Obstetrics and Gynecology, Faculty of Medicine, CUNI, Pilsen, Czechia
NTIS, Faculty of Applied Sciences, University of West Bohemia, Pilsen, Czechia
Institute for the Care of Mother and Child, Prague, Czech Republic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* pelvic organ prolapse stage II (cystocele Ba ≥ -1) * planned surgical treatment (anterior colporrhaphy) * menopausal
Exclusion criteria
* surgical treatment at a location of interest * use of systemic or vaginal estrogens within last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| uniaxial biomechanical analysis | within month after completion of specimens | Young's modulus of elasticity at low and high deformations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quantitative immunohistochemistry -von Willebrand factor (vWF) | within 6 months after completion of specimens | microvessels density (mm-2) The number of von Willebrand factor-positive microvessel profiles was divided by the sum of the areas of the counting frame and expressed as a two-dimensional density of microvessels (QA, quantity per area) |
| quantitative immunohistochemistry -orcein | within 6 months after completion of specimens | elastin fibres - Area fraction ( %) |
| quantitative histological analysis - epithelial thickness | within 6 months after completion of specimens | Hematoxylin-eosin - epithelial thickness (um) |
| molecular analysis - markers of inflammation | within 6 months after results of histological analysis | PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta) |
| molecular analysis - connective tissue remodeling | within 6 months after results of histological analysis | PCR - COLL1 (collagen type I) |
| quantitative immunohistochemistry- picrosirius red | within 6 months after completion of specimens | collagen I and III - Area fraction ( %) |
Countries
Czechia
Outcome results
None listed