Treatment of vaginal atrophy using a low-intensity 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

This study is testing whether a low-intensity laser treatment can improve vaginal health in postmenopausal women who are dealing with vaginal atrophy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Female
• Sponsor: MeLSyTech, Ltd (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Nizhny Novgorod)
• Trial ID: NCT05335317 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of low-intensity neodymium laser treatment on the vaginal wall in postmenopausal women experiencing vaginal atrophy. Participants will be divided into three groups: one receiving laser treatment, another receiving topical hormone therapy, and a control group receiving no treatment. Various assessments, including vaginal health indices and imaging techniques, will be conducted before and after treatment to measure changes in vaginal health. The study will involve up to 120 participants, with follow-up visits scheduled after the treatment procedures.

Who should consider this trial

Good fit: Ideal candidates are women aged 40-75 with vaginal atrophy or mild vaginal prolapse.

Not a fit: Patients with a history of oncological diseases or severe vaginal prolapse will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for women suffering from vaginal atrophy.

How similar studies have performed: Other studies have shown promising results with laser treatments for vaginal atrophy, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.
* The appearance of contraindications listed in the Exclusion criteria.

Where this trial is running

Nizhny Novgorod

• State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko" — Nizhny Novgorod, Russia (RECRUITING)

Study contacts

• Principal investigator: Liya Z Sirotina — Privolzhsky Research Medical University
• Study coordinator: Ksenia V Shatilova, Ph.D.

Conditions: Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse, Neodymium Laser, Laser Treatment, Nanosecond, Laser, Vaginal