NCT05898191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

5.1 years

First QC Date

April 5, 2023

Last Update Submit

December 3, 2023

Conditions

Pelvic Floor DisordersVaginal Atrophy

Outcome Measures

Primary Outcomes (1)

  • uniaxial biomechanical analysis

    Young's modulus of elasticity at low and high deformations

    within month after completion of specimens

Secondary Outcomes (8)

  • quantitative histological analysis - epithelial thickness

    within 6 months after completion of specimens

  • quantitative immunohistochemistry -von Willebrand factor (vWF)

    within 6 months after completion of specimens

  • quantitative immunohistochemistry -orcein

    within 6 months after completion of specimens

  • quantitative immunohistochemistry- picrosirius red

    within 6 months after completion of specimens

  • molecular analysis - markers of inflammation

    within 6 months after results of histological analysis

  • +3 more secondary outcomes

Study Arms (2)

laser

EXPERIMENTAL

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

Other: vaginal laser treatment

control

NO INTERVENTION

no intervention

Interventions

vaginal laser treatmentOTHER

non-ablative vaginal laser application

Also known as: (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy)
laser

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pelvic organ prolapse stage II (cystocele Ba ≥ -1)
  • planned surgical treatment (anterior colporrhaphy)
  • menopausal

You may not qualify if:

  • surgical treatment at a location of interest
  • use of systemic or vaginal estrogens within last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for the care of mother and child

Prague, 147 10, Czechia

Location

Related Publications (9)

  • 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.

    BACKGROUND

  • 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.

    PMID: 28763401BACKGROUND

  • 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.

    PMID: 12786881BACKGROUND

  • 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.

    PMID: 25417568BACKGROUND

  • 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.

    PMID: 20855774BACKGROUND

  • 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.

    PMID: 29033365BACKGROUND

  • 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.

    PMID: 28778337BACKGROUND

  • 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.

    PMID: 33235032BACKGROUND

  • 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.

    PMID: 18799443RESULT

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Lucie Hajkova Hympanova, MD, PhD

    Institute for the Care of Mother and Child, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 5, 2023

First Posted

June 12, 2023

Study Start

February 1, 2019

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)