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Effect of Laser Therapy on Vaginal Tissue

NCT05898191 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

  • Pelvic Floor Disorders
  • Vaginal Atrophy

Interventions

OTHER

vaginal laser treatment

non-ablative vaginal laser application

Sponsors & Collaborators

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

    collaborator UNKNOWN

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

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Lucie Hajkova Hympanova, MD, PhD · Institute for the Care of Mother and Child, Prague, Czech Republic

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Device
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05898191 on ClinicalTrials.gov