Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

Trial design

Treatments tested in this trial

• Laser Treatment

  Device DeviceA medical device, or sometimes a sham device used for comparison, that is being studied.

  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.

  Show more

• Topical hormone estriol

  Drug DrugA medicine being studied. This category can also include a placebo used for comparison.

  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.

• Сlinical blood analysis

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Taking blood from a vein for Clinical blood analysis (to include the participant in the study).

• Сlinical urine test

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Urine sampling for Clinical urine test (to include the participant in the study).

• Vaginal smear

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Vaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency).

• Cervical oncocytology test.

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Cervical smear for oncocytology test (to include the participant in the study).

• Extended colposcopy

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  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).

  Show more

• Pelvic ultrasound

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

• King's Health Questionnaire

  Other intervention Other interventionAn intervention that does not fit one of the standard intervention types.

  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

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  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

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).

• Perineometry

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).

• Optical coherence tomography

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  Optical non-invasive method of investigation vaginal mucus morphological and functional condition.

• Biopsy

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  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

  Diagnostic test Diagnostic testA test used to detect or assess a condition, such as imaging or a laboratory test.

  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).