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Effect of Laser Therapy on Vaginal Tissue

NCT ID: NCT05898191

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2024-03-01

Brief Summary

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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

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Conditions

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Pelvic Floor Disorders Vaginal Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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laser

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

Group Type EXPERIMENTAL

vaginal laser treatment

Intervention Type OTHER

non-ablative vaginal laser application

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vaginal laser treatment

non-ablative vaginal laser application

Intervention Type OTHER

Other Intervention Names

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(Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy)

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Department of Obstetrics and Gynecology, Faculty of Medicine, CUNI, Pilsen, Czechia

UNKNOWN

Sponsor Role collaborator

NTIS, Faculty of Applied Sciences, University of West Bohemia, Pilsen, Czechia

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Lucie Hympanova

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucie Hajkova Hympanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Institute for the care of mother and child

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 28763401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12786881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25417568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20855774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29033365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28778337 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33235032 (View on PubMed)

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.

Reference Type RESULT
PMID: 18799443 (View on PubMed)

Other Identifiers

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UPMDPrague 07032019

Identifier Type: -

Identifier Source: org_study_id