Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug, Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: t
View:

• Age of 40-75 years, inclusive;

• Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;

• All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.

Locations
Other Locations
Russian Federation
State-Funded Healthcare Institution of the Nizhny Novgorod region Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
RECRUITING
Nizhny Novgorod
Contact Information
Primary
Ksenia V Shatilova, Ph.D.
shatilova@melsytech.com
+79262792700
Time Frame
Start Date: 2022-04-18
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 120
Treatments
Experimental: Laser Treatment
Laser treatment of the vagina, vulva, and paraurethral region with a Magic Max laser (Magic Gyno). In total, three procedures will be performed with an interval of 4-6 weeks.~During the procedure, the following sequence of actions will be performed: 1st Stage - vaginal processing with a conical mirror handpiece, 2nd Stage - vaginal processing with a corner mirror handpiece, 3d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
Active_comparator: Topical hormone
Local hormone therapy with estriol. The course of treatment will be of 2 weeks of daily use, and then a maintenance therapy, when the suppository will be used of 2 times a week for 1.5-2 months to prevent symptoms.
Other: No treatment
Participants without vaginal atrophy (no complaints of vaginal health and a vaginal health index greater than 20) and not receiving any treatment.
Related Therapeutic Areas
Sponsors
Leads: MeLSyTech, Ltd

This content was sourced from clinicaltrials.gov