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Pelvic Floor DisordersNCT05898191

Effect of Laser Therapy on Vaginal Tissue

A study testing vaginal laser treatment in people with Pelvic Floor Disorders and Vaginal Atrophy, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pelvic Floor Disorders, Vaginal Atrophy
What is being tested?
vaginal laser treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCzechia
Study dates
1 Feb 2019to 1 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Institute for the care of mother and child

    Prague, 147 10

Other trials in Czechia

About this study

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

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.

Being tested
vaginal laser treatment
Medical subject headings
Pelvic Floor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vaginal laser treatmentOther

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

    non-ablative vaginal laser application

Study groups in NCT05898191
Study groupRoleWhat they receive
laserExperimentallaser treatment (Laser CO² MIXTO PRO, LASERING SRL, Modena, Italy; three sessions, one per month)
Receives: Other: vaginal laser treatment
controlNo interventionno intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. uniaxial biomechanical analysis

    Young's modulus of elasticity at low and high deformations

    Measured: within month after completion of specimens

Secondary outcomes (8)

  1. quantitative histological analysis - epithelial thickness

    Hematoxylin-eosin - epithelial thickness (um)

    Measured: within 6 months after completion of specimens

  2. 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)

    Measured: within 6 months after completion of specimens

  3. quantitative immunohistochemistry -orcein

    elastin fibres - Area fraction ( %)

    Measured: within 6 months after completion of specimens

  4. quantitative immunohistochemistry- picrosirius red

    collagen I and III - Area fraction ( %)

    Measured: within 6 months after completion of specimens

  5. molecular analysis - markers of inflammation

    PCR (polymerase chain reaction) - TGFB (Transforming growth factor beta)

    Measured: within 6 months after results of histological analysis

  6. molecular analysis - markers of inflammation

    PCR - IL- 1 (Interleukin-1)

    Measured: within 6 months after results of histological analysis

  7. molecular analysis - connective tissue remodeling

    PCR - COLL1 (collagen type I)

    Measured: within 6 months after results of histological analysis

  8. molecular analysis - connective tissue remodeling

    PCR - MMP 1 (Matrix Metallopeptidase 1)

    Measured: within 6 months after results of histological analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start1 Feb 2019
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898191
Sponsor's protocol ID
UPMDPrague 07032019
Status last verified
Dec 2023
First submitted
5 Apr 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

  • 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.

    PubMed 28763401

  • 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.

    PubMed 12786881

  • 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.

    PubMed 25417568

  • 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.

    PubMed 20855774

  • 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.

    PubMed 29033365

  • 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.

    PubMed 28778337

  • 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.

    PubMed 33235032

  • 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.

    PubMed 18799443

Questions about this trial

What is this clinical trial studying?

A study testing vaginal laser treatment in people with Pelvic Floor Disorders and Vaginal Atrophy, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

uniaxial biomechanical analysis (time frame: within month after completion of specimens). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898191, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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