Effect of Laser Therapy on Vaginal Tissue

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05898191
• Other study ID #: UPMDPrague 07032019
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2023
• Source: Institute for the Care of Mother and Child, Prague, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Vaginal Atrophy

Intervention

Other:
• vaginal laser treatment
non-ablative vaginal laser application

Locations

Country	Name	City	State
Czechia	Institute for the care of mother and child	Prague

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Czechia, 

References & Publications (9)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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.300.1 — View 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.

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	uniaxial biomechanical analysis	Young's modulus of elasticity at low and high deformations	within month after completion of specimens
Secondary	quantitative histological analysis - epithelial thickness	Hematoxylin-eosin - epithelial thickness (um)	within 6 months after completion of specimens
Secondary	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
Secondary	quantitative immunohistochemistry -orcein	elastin fibres - Area fraction ( %)	within 6 months after completion of specimens
Secondary	quantitative immunohistochemistry- picrosirius red	collagen I and III - Area fraction ( %)	within 6 months after completion of specimens
Secondary	molecular analysis - markers of inflammation	PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta)	within 6 months after results of histological analysis
Secondary	molecular analysis - markers of inflammation	PCR - IL- 1 (Interleukin-1)	within 6 months after results of histological analysis
Secondary	molecular analysis - connective tissue remodeling	PCR - COLL1 (collagen type I)	within 6 months after results of histological analysis
Secondary	molecular analysis - connective tissue remodeling	PCR - MMP 1 (Matrix Metallopeptidase 1)	within 6 months after results of histological analysis