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Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated December 12, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Sep 1, 2024 to Sep 1, 2025
    • Study completion date: Sep 1, 2024 to Dec 1, 2025
    • Study description expanded, about 5 words
    v7
  2. Minor Primary completion date: Apr 30, 2024 to Sep 1, 2024
    • Study completion date: Jun 30, 2024 to Sep 1, 2024
    v6
  3. Minor Study description revisedv5
  4. Minor Study description revisedv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Minor Study description expanded, about 9 wordsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.
Trial Details
NCT Number NCT05335317
Lead Sponsor MeLSyTech, Ltd
Conditions
(from sponsor)
Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
Related terms Uterine Prolapse
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov