Clinical trial NCT05898191: Effect of Laser Therapy on Vaginal Tissue
Official title: Effect of Laser Therapy on Vaginal Tissue at Biomechanical, Histological and Molecular Level in Women With Pelvic Organ Prolapse - Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Floor Disorders
Vaginal Atrophy
Lead sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
Sponsor class: OTHER
Collaborators: name: Department of Obstetrics and Gynecology, Faculty of Medicine, CUNI, Pilsen, Czechia
name: NTIS, Faculty of Applied Sciences, University of West Bohemia, Pilsen, Czechia
First posted: 2023-06-12
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: uniaxial biomechanical analysis
timeFrame: within month after completion of specimens
Secondary outcomes:
measure: quantitative histological analysis - epithelial thickness
timeFrame: within 6 months after completion of specimens
measure: quantitative immunohistochemistry -von Willebrand factor (vWF)
timeFrame: within 6 months after completion of specimens
measure: quantitative immunohistochemistry -orcein
timeFrame: within 6 months after completion of specimens
measure: quantitative immunohistochemistry- picrosirius red
timeFrame: within 6 months after completion of specimens
measure: molecular analysis - markers of inflammation
timeFrame: within 6 months after results of histological analysis
measure: molecular analysis - markers of inflammation
timeFrame: within 6 months after results of histological analysis
measure: molecular analysis - connective tissue remodeling
timeFrame: within 6 months after results of histological analysis
measure: molecular analysis - connective tissue remodeling
timeFrame: within 6 months after results of histological analysis
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for the care of mother and child
Study officials:
affiliation: Institute for the Care of Mother and Child, Prague, Czech Republic
name: Lucie Hajkova Hympanova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
citation: 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.
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