Effect of Laser Therapy on Vaginal Tissue

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vaginal Atrophy; Pelvic Floor Disorders
• Intervention / Treatment: Other: vaginal laser treatment

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 147 10
    • Institute for the Care of Mother and Child

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; no intervention
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: (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
• Collaborators: 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

Publications and helpful links

General 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.
• Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Floor Disorders
• Other Study ID Numbers: UPMDPrague 07032019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes