Effect of Laser Therapy on Vaginal Tissue

Study Overview
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Brief Summary
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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.

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

Conditions
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Pelvic Floor Disorders, Vaginal Atrophy

Intervention / Treatment
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* Other: vaginal laser treatment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser<br>laser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month) | Other: vaginal laser treatment<br>* non-ablative vaginal laser application<br>* Other names: (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy);|
| No Intervention: control<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uniaxial biomechanical analysis | Young's modulus of elasticity at low and high deformations | within month after completion of specimens | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative histological analysis - epithelial thickness | Hematoxylin-eosin - epithelial thickness (um) | within 6 months after completion of specimens | 
| quantitative immunohistochemistry -von Willebrand factor (vWF) | 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) | within 6 months after completion of specimens | 
| quantitative immunohistochemistry -orcein | elastin fibres - Area fraction ( %) | within 6 months after completion of specimens | 
| quantitative immunohistochemistry- picrosirius red | collagen I and III - Area fraction ( %) | within 6 months after completion of specimens | 
| molecular analysis - markers of inflammation | PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta) | within 6 months after results of histological analysis | 
| molecular analysis - markers of inflammation | PCR - IL- 1 (Interleukin-1) | within 6 months after results of histological analysis | 
| molecular analysis - connective tissue remodeling | PCR - COLL1 (collagen type I) | within 6 months after results of histological analysis | 
| molecular analysis - connective tissue remodeling | PCR - MMP 1 (Matrix Metallopeptidase 1) | within 6 months after results of histological analysis |