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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2022
CompletedStudy Start
First participant enrolled
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 12, 2024
December 1, 2024
3.4 years
April 13, 2022
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Change from Baseline of Vaginal Health Index Score
Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: Non=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH (potential of hydrogen) will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5). Score=A+B+C+D+E
2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit
Mean Change from Baseline of Periodic Acid Schiff Reaction Percentage in Vaginal Smear
Part of a cytological test. Histological preparation prepared by liquid-based cytology and stained according to the instructions of the Periodic Acid Schiff kit. The investigator counts 100 cells in field of view with 400x magnification and records the proportion of cells with diffuse and granular staining. Parameter will be measured in percentages (%).
2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 1 month after 4th visit (after the end of any treatment), 3 months after 4th visit
Mean Change from Baseline of Resistive Index by Doppler Sonography
Measurement is a part of ultrasonography. Resistive Index will be measured with US-device. The Resistive Index (RI) is calculated by the following equation: RI = (PSV - EDV) / PSV, where PSV is peak systolic velocity and EDV is end-diastolic velocity, in relative units.
2nd visit (before any treatment);1 month after 4th visit (after the end of any treatment), 3 months after 4th visit, and 6 months after 4th visit
Other Outcomes (20)
Mean Change from Baseline of "General Health Perceptions" Score on the King's Health Questionnaire
2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit
Mean Change from Baseline of "Incontinence Impact" Score on the King's Health Questionnaire
2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit
Mean Change from Baseline of "Role Limitations" Score on the King's Health Questionnaire
2nd visit (before any treatment); 3d visit (4-6 weeks after 2nd visit); 4th visit (4-6 weeks after 3d visit) - the end of any treatment; 1 month after 4th visit, 3 months after 4th visit, and 6 months after 4th visit
- +17 more other outcomes
Study Arms (3)
Laser Treatment
EXPERIMENTALLaser 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.
Topical hormone
ACTIVE COMPARATORLocal 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.
No treatment
OTHERParticipants without vaginal atrophy (no complaints of vaginal health and a vaginal health index greater than 20) and not receiving any treatment.
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MeLSyTech, Ltdlead
Study Sites (1)
State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, 603126, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liya Z Sirotina
Privolzhsky Research Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The treatment method cannot be hidden from the participants and the researcher because of the very different method of treatment: laser treatment and the use of local hormones on their own. However, the specialists involved in the study (cytologist and ultrasound specialist) will not know which group the participant belongs to. The researcher will refer participants (or their materials) to these specialists, indicating their name and visit number. The Researcher will keep a document matching the participant's name and number. The conversation will be held with participants. The participant must not disclose his group when visiting an ultrasound specialist.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 19, 2022
Study Start
April 18, 2022
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- IPD can be shared with researchers starting 3 months after CSR or article publication for five years.
- Access Criteria
- IPD can be shared with researchers only upon an official request from researcher's affiliation institution in the letter form on organization's letterhead paper signed by an authorized person. Official request must be directed by e-mail to the contact person (Ksenia Shatilova, shatilova@melsytech.com). The letter must contain the request purpose and statement of internal IPD use as confidential information only. IPD will be shared after approval by CEO of "MeLSyTech" Ltd according to the company internal rules. A requester will be notified of the decision by official letter. Depending on the decision, a requester will receive a link to the repository, or a justified rejection.
The following data can be shared with researchers upon an official request: * The final version of the Study Protocol approved by the Local Ethics Committee; * Copies of anonymized filled Individual Registration Cards (IRC); * Informed Consent Form (ICF); * Clinical Study Report (CSR) and/or published article (if not contradict the rules and conditions of a journal); * Supplement files systematizing data.