Effect of Laser Therapy on Vaginal Tissue

Not Applicable

Active, not recruiting

• Conditions: Pelvic Floor Disorders; Vaginal Atrophy
• Interventions: Other: vaginal laser treatment

• Registration Number: NCT05898191
• Lead Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser	vaginal laser treatment	laser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month)

Primary Outcome Measures

Name	Time	Method
uniaxial biomechanical analysis	within month after completion of specimens	Young's modulus of elasticity at low and high deformations

Secondary Outcome Measures

Name	Time	Method
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 - IL- 1 (Interleukin-1)
molecular analysis - connective tissue remodeling	within 6 months after results of histological analysis	PCR - MMP 1 (Matrix Metallopeptidase 1)
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 ( %)

Trial Locations

Locations (1)

Institute for the care of mother and child; 🇨🇿 Prague, Czechia