Actively Recruiting
Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
Led by MeLSyTech, Ltd · Updated on 2024-12-12
120
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 40-75 years, inclusive
- Vaginal atrophy or first grade vaginal prolapse with atrophy, or no vaginal atrophy for no treatment group
- Informed consent to follow study procedures, visits, and tests
You will not qualify if you...
- Age under 40 or over 75 years
- History of oncological diseases
- Active tuberculosis
- Inflammatory diseases of the vulva and vagina including acute genital herpes
- Urinary tract infections
- Damage to the vaginal mucosa
- Pregnancy
- Tendency to photoallergy including use of photosensitizing drugs
- Porphyria
- Cardiac deficiency of 2nd or 3rd degree
- Chronic kidney disease
- Vaginal prolapse greater than 1st grade
- Women within 8 weeks postpartum
- Inability to complete the study as judged by a doctor
- Non-compliance with laser treatment sessions
- Voluntary withdrawal from the study
- Violation of post-laser treatment recommendations
- Adverse events related to laser treatment or study procedures
- Development of any exclusion criteria during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, Russia, 603126
Actively Recruiting
Research Team
K
Ksenia V Shatilova, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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