Effect of Laser Therapy on Vaginal Tissue
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: laser laser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month) |
Other: vaginal laser treatment
non-ablative vaginal laser application
Other Names:
|
| No Intervention: control no intervention |
Outcome Measures
Primary Outcome Measures
- uniaxial biomechanical analysis [within month after completion of specimens]
Young's modulus of elasticity at low and high deformations
Secondary Outcome Measures
- quantitative histological analysis - epithelial thickness [within 6 months after completion of specimens]
Hematoxylin-eosin - epithelial thickness (um)
- 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 immunohistochemistry- picrosirius red [within 6 months after completion of specimens]
collagen I and III - Area fraction ( %)
- molecular analysis - markers of inflammation [within 6 months after results of histological analysis]
PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta)
- molecular analysis - markers of inflammation [within 6 months after results of histological analysis]
PCR - IL- 1 (Interleukin-1)
- molecular analysis - connective tissue remodeling [within 6 months after results of histological analysis]
PCR - COLL1 (collagen type I)
- molecular analysis - connective tissue remodeling [within 6 months after results of histological analysis]
PCR - MMP 1 (Matrix Metallopeptidase 1)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute for the care of mother and child | Prague | Czechia | 147 10 |
Sponsors and Collaborators
- Institute for the Care of Mother and Child, Prague, Czech Republic
- Department of Obstetrics and Gynecology, Faculty of Medicine, CUNI, Pilsen, Czechia
- NTIS, Faculty of Applied Sciences, University of West Bohemia, Pilsen, Czechia
Investigators
- Principal Investigator: Lucie Hajkova Hympanova, MD, PhD, Institute for the Care of Mother and Child, Prague, Czech Republic
Study Documents (Full-Text)
None provided.More Information
Publications
- Conte C, Jauffret T, Vieillefosse S, Hermieu JF, Deffieux X. Laser procedure for female urinary stress incontinence: A review of the literature. Prog Urol. 2017 Dec;27(17):1076-1083. doi: 10.1016/j.purol.2017.09.003. Epub 2017 Oct 21.
- Cruz VL, Steiner ML, Pompei LM, Strufaldi R, Fonseca FLA, Santiago LHS, Wajsfeld T, Fernandes CE. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018 Jan;25(1):21-28. doi: 10.1097/GME.0000000000000955.
- Hympanova L, Rynkevic R, Mori Da Cunha MGMC, Diedrich CM, Blacher S, De Landsheere L, Mackova K, Krofta L, Roovers JP, Deprest J. The ewe as an animal model of vaginal atrophy and vaginal Er:YAG laser application. Menopause. 2020 Nov 23;28(2):198-206. doi: 10.1097/GME.0000000000001679.
- Kauvar AN. Fractional nonablative laser resurfacing: is there a skin tightening effect? Dermatol Surg. 2014 Dec;40 Suppl 12:S157-63. doi: 10.1097/DSS.0000000000000200.
- P. Gupta, M. J. Ehlert, and J. M. Bartley, "Diagnosis and Management of Complex Pelvic Floor Disorders in Women," vol. 22, no. 6, pp. 275-285, 2015.
- Papadavid E, Katsambas A. Lasers for facial rejuvenation: a review. Int J Dermatol. 2003 Jun;42(6):480-7. doi: 10.1046/j.1365-4362.2003.01784.x.
- Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.
- Reilly MJ, Cohen M, Hokugo A, Keller GS. Molecular effects of fractional carbon dioxide laser resurfacing on photodamaged human skin. Arch Facial Plast Surg. 2010 Sep-Oct;12(5):321-5. doi: 10.1001/archfacial.2010.38.
- UPMDPrague 07032019