search
Back to results

Effect of Laser Therapy on Vaginal Tissue

Primary Purpose

Pelvic Floor Disorders, Vaginal Atrophy

Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
vaginal laser treatment
Sponsored by
Institute for the Care of Mother and Child, Prague, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pelvic Floor Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for the care of mother and child

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

laser

control

Arm Description

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

no intervention

Outcomes

Primary Outcome Measures

uniaxial biomechanical analysis
Young's modulus of elasticity at low and high deformations

Secondary Outcome Measures

quantitative histological analysis - epithelial thickness
Hematoxylin-eosin - epithelial thickness (um)
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)
quantitative immunohistochemistry -orcein
elastin fibres - Area fraction ( %)
quantitative immunohistochemistry- picrosirius red
collagen I and III - Area fraction ( %)
molecular analysis - markers of inflammation
PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta)
molecular analysis - markers of inflammation
PCR - IL- 1 (Interleukin-1)
molecular analysis - connective tissue remodeling
PCR - COLL1 (collagen type I)
molecular analysis - connective tissue remodeling
PCR - MMP 1 (Matrix Metallopeptidase 1)

Full Information

First Posted
April 5, 2023
Last Updated
May 31, 2023
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
search

1. Study Identification

Unique Protocol Identification Number
NCT05898191
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Vaginal Atrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser
Arm Type
Experimental
Arm Description
laser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month)
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
vaginal laser treatment
Other Intervention Name(s)
(Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy)
Intervention Description
non-ablative vaginal laser application
Primary Outcome Measure Information:
Title
uniaxial biomechanical analysis
Description
Young's modulus of elasticity at low and high deformations
Time Frame
within month after completion of specimens
Secondary Outcome Measure Information:
Title
quantitative histological analysis - epithelial thickness
Description
Hematoxylin-eosin - epithelial thickness (um)
Time Frame
within 6 months after completion of specimens
Title
quantitative immunohistochemistry -von Willebrand factor (vWF)
Description
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)
Time Frame
within 6 months after completion of specimens
Title
quantitative immunohistochemistry -orcein
Description
elastin fibres - Area fraction ( %)
Time Frame
within 6 months after completion of specimens
Title
quantitative immunohistochemistry- picrosirius red
Description
collagen I and III - Area fraction ( %)
Time Frame
within 6 months after completion of specimens
Title
molecular analysis - markers of inflammation
Description
PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta)
Time Frame
within 6 months after results of histological analysis
Title
molecular analysis - markers of inflammation
Description
PCR - IL- 1 (Interleukin-1)
Time Frame
within 6 months after results of histological analysis
Title
molecular analysis - connective tissue remodeling
Description
PCR - COLL1 (collagen type I)
Time Frame
within 6 months after results of histological analysis
Title
molecular analysis - connective tissue remodeling
Description
PCR - MMP 1 (Matrix Metallopeptidase 1)
Time Frame
within 6 months after results of histological analysis

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucie Hajkova Hympanova, MD, PhD
Organizational Affiliation
Institute for the Care of Mother and Child, Prague, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for the care of mother and child
City
Prague
ZIP/Postal Code
147 10
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
PubMed Identifier
28763401
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.
Results Reference
background
PubMed Identifier
12786881
Citation
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.
Results Reference
background
PubMed Identifier
25417568
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.
Results Reference
background
PubMed Identifier
20855774
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.
Results Reference
background
PubMed Identifier
29033365
Citation
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.
Results Reference
background
PubMed Identifier
28778337
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.
Results Reference
background
PubMed Identifier
33235032
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.
Results Reference
background
PubMed Identifier
18799443
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.300.11.1311.
Results Reference
result

Learn more about this trial

Effect of Laser Therapy on Vaginal Tissue

We'll reach out to this number within 24 hrs