Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
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
MeLSyTech, Ltd
120 participants
Apr 18, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria18
- Age of under 40 and over 75 years old;
- History of oncological diseases;
- Active tuberculosis;
- Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;
- Urinary tract infections;
- Damage to the vaginal mucosa;
- Pregnancy;
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Cardiac deficiency of 2-3 degrees;
- Chronic renal disease;
- Participants with greater than 1st grade vaginal prolapse;
- Women after childbirth up to 8 weeks;
- Participants who, according to the doctor, are not able to complete the study;
- Protocol non-compliance of laser exposure sessions;
- Voluntary refusal to participate in the study;
- Violation of recommendations for the management of the period after laser treatment;
- Adverse events that occurred during laser processing and research, and associated with them.
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Interventions
Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ. General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50% overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm (total handpiece length of 10 centimeter (cm), 20 treatment points along vagina), from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 100 milliseconds (ms), pause between packets of 50 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s. The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth.
Estriol suppository ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Active ingredient of 0.5 milligram in 1 suppository. Daily dose will be 1 suppository.
Taking blood from a vein for Clinical blood analysis (to include the participant in the study).
Urine sampling for Clinical urine test (to include the participant in the study).
Vaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency).
Cervical smear for oncocytology test (to include the participant in the study).
Extended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study).
Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).
Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).
Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).
Optical non-invasive method of investigation vaginal mucus morphological and functional condition.
Biopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography.
Femoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study).
Locations(1)
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NCT05335317